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.
Qualifications
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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