Sunday, July 25, 2010

Quality Engineer

Quality Engineer.

Among these are products for reconstructing damaged or diseased joints; repairing and reconstructing traumatic skeletal injuries; facilitating the treatment of spinal disorders and deformity; surgical treatment of neurological and central nervous system disorders, and sports medicine devices for the treatment of soft tissue injuries.

The Quality Engineer will assist in the development, implementation and maintenance of quality systems and provide technical contribution in a team environment. May specialize in areas supporting product development, in-house production, or supplier management as they apply to Quality Systems or may otherwise specialize in one or more specific product group(s)/processes. Works independently on routine tasks; may require supervision to resolve more complex issues. Will be exposed to office working conditions with frequent exposure to plant conditions and occasionally a laboratory environment. Will have intimate knowledge of research and product development, trade secrets, government reporting and legal matters, and strategic quality initiatives. External customers/contacts include outside technical contractors, suppliers, consultants, second and third part auditors, and researchers. Internal customers may include Product Development, Research, Operations, Marketing, Legal, Sales, Clinical, Human Resources, Quality and Regulatory departments. Performs all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information.
The Quality Engineer will participate in design and process risk analysis (e.g., FMEAs), develops and executes design and manufacturing process validations/verifications and determines appropriate sampling plans for subsequent routine production. Devises and implements methods and procedures for inspecting, testing and evaluating production. Provides technical Quality support to assigned inspection and manufacturing area(s). Develops solutions to problems of moderate scope and complexity. Contributes to the functional milestones associated with specific projects. May monitor and analyze supplier and/or internal performance and nonconforming product data to identify products or processes requiring quality improvements. Determines and implements the appropriate corrective actions. Performs internal and/or supplier audits (Supplier Management). Participates in pre-production activities for new and transferred products. Analyzes data and identifies trends to improve quality systems' overall compliance, effectiveness, and efficiency. Investigates internal and external system failures and ensures successful resolution. Maintains systems' inspection readiness. May participate in the training of entry level Quality Engineers. Attends management meetings and gives oral technical presentations. Responsible for achieving the goals and objectives of the NPD Project Core Team, which includes participating in PCT meetings, completing functional assignments, problem solving and meeting defined milestones and deliverables, which leads to timely project commercialization in a positive team environment.

A minimum of a Bachelors degree, preferably in a technical discipline, is required. A minimum of 2+ years of Engineering or Quality experience related to this role is required. A minimum of 2+ years experience within a regulated environment is required, or 1+ year experience in a regulated environment with an advanced degree. Experience in an FDA regulated environment is an asset. Process Excellence, ASQ, Lean Manufacturing training and/or certifications are an asset. Process validation and verification activity experience is an asset. Risk analysis techniques, including FMEA (Failure Modes and Effects Analysis) or other methods, is required. Problem solving techniques including root cause analysis and cause and effect analysis are an asset. Statistical techniques and methods are an asset. Blue print reading and interpretation including Geometric Dimensioning and Tolerancing (GD&T) is an asset. Must have strong negotiation skills and the ability to apply good manufacturing/laboratory practices (GMP and GLP). Working knowledge of QSR and ISO 13485 (ISO9001/EN46001) quality system requirements are an asset. Prior project management experience would be preferred. Working knowledge of Microsoft Word and Excel are required, with Access, Project, and PowerPoint knowledge an asset. Excellent written and oral communication skills will be required. The ability to work independently and partner with a cross-functional team is required. The qualified candidate for this hands-on position should be able to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision.

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Chemical Engineer

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Reporting to the Plant Manager and R&D Leader, this position is responsible for support of manufacturing operations and process scale-up, process and equipment improvement activities. Manage projects to evaluate, analyze, and improve existing processes, support the development of new manufacturing processes, implement statistical process controls, analyze and trend existing process parameters, improve manufacturing yields, reduce scrap, and error proof manufacturing processes. Maintain and upgrade process equipment, plan, develop, and validate equipment and processes to meet the demands of new product introductions and current manufacturing operations.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Responsible for process engineering and project management to support process scale-up and current manufacturing operations. These projects are typically of increased complexity, and can pose significant risk to product and processes if not designed and implemented correctly.

Responsible for total Project Management aimed to evaluate, analyze, and improve existing processes, support the development of new manufacturing processes, and manufacturing process troubleshooting. Must be able to manage the projects in their entirety, and also be able to perform/deliver specific project tasks as necessary.

Manage projects to implement statistical process control, analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.

Initiate, develop and implement IQ/OQ/PQ validations for equipment and processes to meet the demands of new product introductions and current manufacturing operations.

Coordinate specific efforts of the project team, including the core team members (Manufacturing, Plant QA/QC, Facilities, Materials Management, and Engineering) and supporting members (Health-Safety-Environmental (HSE), Finance, etc.). Includes such tasks as development of Manufacturing process requirements, accounting documentation, specifications, validations, ECN, PCN, and Engineering drawings.

Assemble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and HSE.

Perform timely technical investigations and provide practical manufacturing solutions, under appropriate safety and environmental regulatory guidelines. As required, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective & Preventive Action(s).

Lead and manage efforts to create novel processes leading to full scale manufacturing of Electrical Safety products. These solutions are often unique and creative in nature to improve specific processes.

Provide daily analytical and technical support to meet manufacturing objectives

Responsible for providing plant input in manufacturing process development, to include but not limited to, process design requirements, risk analysis, traceability matrix, design history file, etc.

Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full scale manufacturing. Maintain and upgrade process equipment, plan, develop, and validate equipment to meet the demands of new product introductions and current manufacturing operations.  

Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.

Ensure that all appropriate documentation, drawings specifications are generated in compliance with procedures and statutory requirements.

Provide technical input for analysis of process and equipment changes

Basic Qualifications:

BS in Mechanical Engineering, Chemical Engineerig, Manufacturing Engineering, or equivalent

0 to 5 years experience in the chemical industry with experience in process development.

Preferred Qualifications:

MS in Mechanical Engineering, Chemical Engineering, Manufacturing Engineering, or Equivalent.

knowledge in polymer industry.

Experience in rubber product manufacturing, bulk material processing, chemical or related industry.

Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, QSR, ISO, and Design Control and Regulatory Procedures is required.

Experience with statistical process tools required (SPC, Minitab, other statistical software).

Experience in processing rubber (natural and synthetic), or other polymer materials.

General chemistry, processing and materials expertise

Considerable knowledge of the principles and practices of engineering as applied to various types of projects.

Ability to prepare complex reports, project summaries, and correspondence.

Exceptional practical problem solving skills, excellent organizational and communication skills
with demonstrated matrix organization leadership.  Multi-Site experience a plus.
Practical product fabrication a plus.
LEAN experience (Lean Master Certification), a plus
"Green Belt" certification; Black Belt preferred.

Database Administrator Sr Professional


Database Administrator - Full time opportunity. Will perform Database Administration for all production, test, and development databases.
  • Must be able to support a 24X7 production environment.
  • Minimum 12 months of recent experience supporting production Oracle databases OR 3 years recent experience supporting Oracle databases in a development environment
  • Linux and AIX or other Unix experience
  • Oracle 10g RAC, Data Guard, and Grid Control experience
  • SQL Server experience
Essential Job Functions
  • Monitors database activity and file usage, and ensures necessary resources are present. Determines data to collect and analyzes information as appropriate. Investigates and resolves technical database issues of significance.
  • Oversees the analysis and determination of database performance characteristics, informational needs and elements, data relationships and attributes, proposed manipulation, data flow and storage requirements, and data output and reporting capabilities for more complex databases. Recommends and implements tuning opportunities to improve system response and run times.
  • Defines logical attributes and data inter-relationships and designs complex data structures to accommodate database production implementation, storage, maintenance and accessibility to enhance performance.
  • Optimizes database accessibility by developing load balancing architectures and processes to eliminate down time for backup processes. Limits database accessibility based upon information security level and ensures data spillage from more secure to less secure databases does not occur.
  • Implements and supports database security regulations, policies, and guidelines. Monitors security bulletins to obtain information of potential threats; installs necessary security patches to ensure ongoing database security.
  • Plans and installs upgrades of database management systems (DBMS) software as necessary to enhance database performance. Researches various hardware and software products; recommends solution and implements approved products.
  • Functions as a technical project leader or provides work leadership for less experienced personnel on a portfolio of databases, including installations and upgrades of DBMS software and backup/recovery strategies. Reviews and approves application and database design decisions to ensure that application solutions exhibit high levels of performance, security, scalability, maintainability, and reliability upon deployment.
  • Assists project managers in the development of project plans including detailed project estimates and tasks required for database activities. Utilizes standard corporate tools to record change and problem activities for tracking purposes.
  • Integrates databases and commercial of the shelf software; resolves conflicts between databases and of the shelf software, operating systems, and open source applications.
  • Designs and tests database installation, implementation, and recovery scenarios. Determines test to use and collects appropriate data according to established guidelines. Participates in analysis, development and implementation of unique database recovery plans in response to client-impacting outages.


Basic Qualifications

  • Bachelor's degree or equivalent combination of education and experience
  • Bachelor's degree in computer science, management information systems, or related field preferred
  • Six or more years of experience in database design or maintenance
  • Experience working with computer hardware and software installation/upgrading procedures
  • Experience working with database and system maintenance procedures
  • Experience working with database creation techniques and database management systems (DBMS) features
  • Experience working with database performance tuning

Other Qualifications

  • Good analytical and problem solving skills
  • Good programming skills for database management and general software
  • Good communication skills
  • Leadership skills to guide work teams
  • Ability to work in a team environment
  • Ability to anticipate problems and take decisive action
  • Willingness to travel

Finance Manager

Responsibilities include:
Review detailed support for 10Q/10K
Coordinate the timely filing of unclaimed property including review of detailed reconciliation of A/R, A/P and Payroll
Financial planning and forecasting 
Debt and interest rate swap accounting 
Review forecast-to-actual variance analysis and other ad-hoc financial analysis as needed 
Supervise two staff-level accountants 
Review journal entries, month-end reconciliations and daily cash forecast

Sr. Manager, System Integration Testing


Manage, train and develop quality assurance staff members under the selected candidate's direct supervision.
Produce and maintain Key Performance Indicators (KPIs) around the testing performed with in the team.
Manage a continuous process improvement program within the team.
Review technical specifications and provide work estimations.
Partner with project management in the development of project plans, status communications, and the management of development software solutions.
Create test strategies, test plans, re-usable test scenarios and champion automation efforts.
Responsible for the preparation of test environments and test data.
Manage the availability and reliability of multiple QA environments that are used to test new software and the software deployments for Comcast front office, billing platform, and statement application.
Provide regular communication of project status and issues requiring escalation.
Prepare presentations and communicate with all levels inside Comcast and with external vendors.
Manage purchase request process for contract resources and hardware resources needed to maintain the QA environments.

Required Skills:
Bachelors/Masters of Science degree in a computer science or electrical engineering or equivalent in work experience bringing new technologies to market in highly complicated, ambiguous, fast pace business environments:

10+ years progressive responsibility and experience in systems engineering.
At least 5+ years managing medium to large technology-based teams.
Strong knowledge of QA methodology is required.
Strong knowledge of Testing tools like HP/Mercury products and/or Rational tools.
Srong knowledge of Service Oriented Architecture.
Strong team leadership and management skills leading engineering and test personnel.
Knowledge of Test Driven Development TDD software process or Agile software development process is required.
Knowledge of Call Center processes, main frame, web testing, and billing.
Knowledge of SOAPUI and Webservices Testing (HP Service Test) preferred.
A background in development is a big plus.
Rapidly grasps new technology and abstraction; stays in tune with evolving technologies/standards.
Must possess the ability to maintain balance between multiple perspectives: customer, business, technical and operations.
Excellent presentation and communication skills a must
Must be a team player, able to work closely with cross-functional development groups.
Knowledge of video architectures is preferred.