Senior Quality Engineer
AIM Plastics is an ISO 9001 / ISO 13485 certified company that fully understands that quality is the foundation of our business. We provide service to the medical device industry. AIM Plastics is looking for a full-time, direct hire Senior Quality Engineer with plastic injection molding experience to start immediately. Industry competitive wage and benefits apply.
BASIC FUNCTION:
- Interface with customers on dimensional requirements, results and approvals as required.
- Quality lead for audit findings, including internal and external corrective and preventative actions (CAPA).
- Interface with engineering, manufacturing and quality assurance to ensure manufacturing processes and products comply with specified requirements.
- Develop and control production PPAP documentation.
- Lead and support quality functions on production floor.
- Data collection and analysis, working knowledge of Minitab and DIS reporting preferred.
- Knowledge in statistical methods, GD&T and blueprint reading.
- Develop, implement and control revisions to production and inspection work instructions and procedures.
- Assist risk analysis on current and new product and processes.
QUALIFICATIONS
- Associates Degree and (5) years of job related experience in plastic injection molding.
- Hands on experience with writing and executing APQP documents and Corrective/Preventative Action process.
- Understand and be able to apply statistical techniques.
- Extensive knowledge of and adherence to quality systems and working knowledge of ISO 9001 and ISO 13485.
- Excellent technical writing skills.
- Proficient in Microsoft Office, Word, Excel, etc.
- Able to lift 30 pounds minimum on a regular basis.
- Proficiency in print reading / GD&T a must.
- Background in medical device field preferred.
- Must be dependable with strong organizational skills, ability to follow through a must.
