- 650 Hwy 74 S, Peachtree City, GA 30269, USA
Gerresheimer is a leading global partner to the pharma and healthcare industry. With our specialty glass and plastic products, we contribute to health and well-being. We have worldwide operations and about 10,000 employees manufacture our products in local markets, close to our customers.
1. Provide Validation input (DOE, FAT, SAT) to cross-functional teams involving R&D, Marketing, Regulatory, developing medical devices.
2. Support line transfers, qualification and verification activities at site
3. Support supplier selection activities, address quality issues as they arise
4. Develop statistically relevant test methods, protocols and documentation to support manufacturing of medical devices.
5. Develop validated plans for joining operations like ultrasonic welding
6. Conduct technical reviews; ensure documentation is available to meet Quality Systems Requirements. (BOMs, Routers, FMEAs, etc.).
7. Actively participates in concept review and development on new injection-molded products.
8. Support various teams and work closely with Design Engineering and Project Management to smoothly transition new products to production. Provide frequent and appropriate communications with all internal customers
9. Stay current on core competencies and best practices in manufacturing to ensure incorporation into new qualifications / validations.
10. Identify root cause and implements corrective and preventive measures to improve or ensure product quality across product lines.
11. Ensure product documentation and manufacturing processes meet all Quality system requirements.
12. Designs, installs, and continually evaluate quality assurance and/or control methods and Systems.
13. Conduct statistical analysis in the form of capability studies to evaluate processes.
14. Develop standards, procedures, and work instructions.
15. Apply in-depth knowledge of statistical techniques, with ability to identify, analyze and define possible solutions for continuous product and process improvement
16. Perform training in internal auditing, mechanical inspection and statistical techniques
17. Develop sampling plans and statistical methods to be utilized by manufacturing and inspection to include determination of control points and charting methods.
18. Interface with engineering and CMM programmers to design fixtures and processes to ensure the effectiveness of measurement systems.
19. Conduct internal and external audits and supplier surveys to verify capability and/or compliance.
20. Coordinate and participate in material review activities to determine nonconforming product dispositions and corrective actions.
21. Develop and generates reports to identify trends.
22. Plan, conduct and take action regarding gauge R&R, product and process capability studies.
1. 4 year Engineering Degree or equivalent experience.
2. Minimum of 5 years of experience in the areas of quality management in the medical device field preferably minimally invasive, single use medical devices in the endoscopy, cardiovascular, neurovascular, and urology markets. Ideally project management experience in the product or process development of plastic components.
3. Ability to apply engineering principles to an idea or set of user requirements -- and then convert this into design requirements, considering manufacturability, cost of goods, and the regulatory requirements for a device or combination product.
4. Ability to develop injection molding and Assembly Validation Master plans.
5. Expertise in plastics testing – particularly ASTM and ISO mechanical tests.
6. Knowledge of plastics materials – structure, properties, rheology and processing behavior of plastics and elastomers.
7. Familiarity with chemical and thermal characterization of plastics.
8. Ability to make data-based and risk-based decisions to drive projects efficiently.
9. Good understanding of Design for Manufacturability principals, GAMP5, UL and EU electrical standards.
10. Expertise of FDA regulations and validation of automation equipment, i.e. SAT, FAT, IQ, OQ, PQ.
11. Proficient with Microsoft Project, Minitab, and very proficient in Microsoft Office products.
12. Ability to communicate vertically and horizontally through multiple channels to motivate diverse teams, and enable cross-functional collaboration.
13. 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.
Continuous improvement methodologies (e.g. Six Sigma, lean manufacturing, etc.) and change management methodologies.
All your information will be kept confidential according to EEO guidelines.