- Internships /
- SR. QUALITY ENGINEER
SR. QUALITY ENGINEERBookmark This
Gerresheimer MPS - Peachtree City
Posted: November 15 2016
Always be on the alert for potentially fraudulent job postings online - never send money to a potential employer.
Gerresheimeris a leading global partner to the pharma and healthcare industry. With specialty glass and plastic products the company contributes to health and well-being. Gerresheimer has worldwide operations and its 11,000 employees manufacture products in local markets, close to its customers. With over 40 plants in Europe, North America, South America and Asia, Gerresheimer generates revenues of more than EUR 1.2 billion. The comprehensive product portfolio includes pharmaceutical packaging and products for the safe, simple administration of medicines: Insulin pens, inhalers, and closures with closure and safety systems as well as packaging for the cosmetics industry.
Gerresheimer Medical Systems is seeking an experienced Sr. Quality Engineer to join the team in Peachtree City, GA. This is a 1st shift 8-5 Monday-Friday.
Sr. Quality Engineers will be responsible for the quality/validation support of production injection molding and assembly. Work cross-functionally to lead validation of new products and ensures transfer of validated processes and assets into production.
4 year Engineering Degree or equivalent experience.
Minimum of 5 years of experience in the areas of quality management in the medical device field preferably minimally invasive, single use medical devices. Ideally validation experience in the product or process development of plastic components and assemblies.
Ability to apply engineering principles to an idea or set of user requirements -- and then convert this into the regulatory requirements for a device or combination product.
Ability to develop injection molding and assembly Validation Master Plans.
Experience in plastics testing – particularly ASTM and ISO mechanical tests.
Ability to make data-based and risk-based decisions to drive projects efficiently.
Good understanding of Design for Manufacturability principals, GAMP5, UL and EU electrical standards.
Expertise of FDA regulations and validation of automation equipment, i.e. SAT, FAT, IQ, OQ, PQ.
Proficient with Microsoft Project, Minitab, and very proficient in Microsoft Office products.
Ability to communicate vertically and horizontally through multiple channels to motivate diverse teams, and enable cross-functional collaboration.
Authoritative command of complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and influence decision-making.
Provide Validation input (DOE, FAT, SAT, DQ, IQ, OQ, PQ) to cross-functional teams involving R&D, Marketing, Regulatory, developing medical devices.
Support line transfers, qualification and verification activities at site
Support supplier selection activities, address quality issues as they arise
Develop statistically relevant test methods, protocols and documentation to support manufacturing of medical devices.
Conduct technical reviews; ensure documentation is available to meet Quality Systems Requirements. (BOMs, Gage R&R, FMEAs, etc.).
Actively participates in concept review and development on new injection-molded products.
Support various teams and work closely with Project Management to smoothly transition new products to production. Provide frequent and appropriate communications with all internal customers
Stay current on core competencies and best practices in manufacturing to ensure incorporation into new qualifications / validations.
Identify root cause and implements corrective and preventive measures to improve or ensure product quality across product lines.
Ensure product documentation and manufacturing processes meet all Quality system requirements.
Designs, installs, and continually evaluate quality assurance and/or control methods and Systems.
Conduct statistical analysis in the form of capability studies to evaluate processes.
Develop standards, procedures, and work instructions.
Apply in-depth knowledge of statistical techniques, with ability to identify, analyze and define possible solutions for continuous product and process improvement
Develop sampling plans and statistical methods to be utilized by manufacturing and inspection to include determination of control points and charting methods.
Interface with engineering and CMM programmers to validate fixtures and processes to ensure the effectiveness of measurement systems.
Conduct internal and external audits and supplier surveys to verify capability and/or compliance.
Coordinate and participate in material review activities to determine nonconforming product dispositions and corrective actions.
Plan, conduct and take action regarding gauge R&R, product and process capability studies.
Occasional travel to offshore locations may be required up to 25%.