Senior Quality Engineer
1 week ago
The Quality Engineer assists in the implementation and maintenance of all quality system requirements including APQP, PPAP, customer concerns and customer visits, gauging, process control plans, supplier issues, ISO 13485 & AS9100 elements, customer specific requirements.
Typical Duties and/or Responsibilities:
- Ensure/Provide quality related documents to the manufacturing floor, including control plans, control cards, visual aids and work instructions as part of the New Product Introduction process.
- Perform QA Feasibility Review for new products.
- Prepare and submit Production Part Approval Process (PPAP) packages ensuring all elements are met per customer requirements.
- Collect and analyze statistical process control (SPC) data to optimize manufacturing processes including gage repeatability and reproducibility (Gage R&R) studies.
- Prepare Process Validation documentation (OQ-PQ) as needed
- Create customer C of C for inclusion into Method of Manufacture and shipping requirements
- Create work instructions.
- Work with QA Laboratory & CMM Lead to create/modify programs for automated inspection equipment such as CMMs, vision systems and optical comparators.
- Complies with policies and procedures pertaining to facility or divisional adopted standards such as ISO 13485 & AS9100.
- Utilizes the concepts of continuous improvement including Lean
- Ensures Housekeeping and Health & Safety Standards are maintained.
Qualifications:
- Ability to read and interpret engineering drawings and specifications.
- Knowledge of Geometric Dimensioning and Tolerancing (GDT) standards and use
- Experience with dimensional measurement equipment including CMMs, optical comparators, vision systems, calipers, micrometers and bore gages
- Working knowledge of sub-contract process is required (plating, grinding, heat treating, passivation, etc.).
- Ability to solve complex problems and exercise judgment based on the analysis of multiple sources of information.
- Ability to support and/or lead root cause analysis, disciplined problem-solving and decision-making processes.
- Strong quantitative skills including the use of statistics for decision making processes
- Proven leadership, interpersonal skills and personal development skills.
- Proficient in Microsoft Office.
- Highly organized with strong documentation skills
- Good interpersonal and communication skills.
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