Gerresheimer Medical Plastics Systems is seeking an experienced Quality Engineer to join the team in Peachtree City, GA. This is a 1st shift job from 8:00 AM - 5:00 PM.
The Quality Engineer is responsible for the advanced technical support of the Quality Assurance and Control Department within an injection molding and assembly production facility. Provide technical guidance and know-how for the Quality control lab (IPC) personnel. Provide technical input for all product quality related aspects. Interface with production and customers on product quality related aspects. Process ownership for all Quality Labs and Product Quality related processes. Works cross-functionally to interface to process development of complex technologies on new products and ensure efficient and effective transfer of product into production. Support or oversee process validations to ensure compliance to acceptance criteria, and data analysis to ensure that validation data is normal.
Responsibilities: Roles, Tasks
• Support line transfers, qualification and verification activities at site
• Develop statistically relevant test methods, protocols and documentation to support manufacturing of medical devices.
• Support or develop control plans based on customer specifications and FMEAs
• Conduct technical reviews; ensure documentation is available to meet Quality Systems Requirements. (BOMs, drawings, FMEAs, Specifications, etc.).
• Actively participates in concept review and development on new injection-molded products.
• 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
• 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.
• Support the CAPA process as needed.
• 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
• Perform training in mechanical inspection and statistical techniques
• 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 design fixtures and processes to ensure the effectiveness of measurement systems.
• Conduct internal and external audits and supplier surveys to verify capability and/or compliance to customer and regulatory requirements.
• Coordinate and participate in material review activities to determine nonconforming product dispositions and corrective actions.
• Develop and generates reports to identify trends in quality.
• Plan, conduct and take action regarding gauge R&R, calibration, product and process capability studies.
• Occasional travel to offshore locations may be required up to 10%.
Requirements: Education, Experience
• 4 year Engineering Degree or equivalent experience.
• Minimum of 2 years of experience in the areas of quality control /assurance in a medical device field or in the field of other medical disposables / non disposables.
• Project management experience in the product or process development of plastic components is desirable.
• 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 (Design of Manufacturability Principles).
• Excellent understanding of applying statistical methods.
• Familiarity with risk assessment tools like FMEA
• Experienced in plastics testing - particularly ASTM and ISO mechanical tests.
• Knowledge of plastics materials is desirable - structure, properties, rheology and processing behavior of plastics and elastomers.
• Knowledge of typical molding or mold related failure modes/defects.
• Familiarity with chemical and thermal characterization of plastics.
• Ability to make data-based and risk-based decisions to drive projects efficiently.
• FDA regulations and validation procedures, i.e. IQ, OQ, PQ.
• Proficient with statistical tools like 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.
• Ability to lead cross functional teams in CAPA processes, Change Management processes and continuous improvement processes.
Excellent problem solving and organizational skills. Ability to analyze data for root cause analysis.
Gerresheimer is 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, prefillable syringes, injection vials, ampoules, bottles and containers for liquid and solid medicines with closure and safety systems as well as packaging for the cosmetics industry.
Peachtree City, GA
Fri, 9 Jun 2017 08:16:46 PDT