Quality Systems Supervisor
Phillips-Medisize, a Molex Company, is seeking a Quality Systems Supervisor (also supporting NPI) to ensure highly effective and efficient systems for internal audits, corrective actions, continuous improvement, and related business systems.
What You Will Do In Your Role
- Ensure quality management system is kept current with changing FDA/ISO requirements
- Coordinate document control activities related to procedures, work instructions and form control
- Provide input to daily management quality metrics, including establishing key performance measures, means of data collection, and reporting
- Facilitate quality systems training activities; such as for CAPA, Audits, etc.
- Oversee Corrective & Preventive Action process, Internal Audit Process
- Actively participate in corporate/cross-facility teams to develop and implement new and improved systems; such as with myQMS, SAP, and site-registration of 21 CFR Parts 820, 210 & 211
- Provide direction and leadership to Quality Systems staff; including establishing clear objectives, managing performance, effective communication, fostering a team environment, talent acquisition, career development, and addressing disciplinary issues
- Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction
- Support NPI project teams in the creation and completion of validation, DMR, control plan, metrology, and risk management documentation (as necessary)
- Support NPI project teams in the analysis of metrology data, and work with team to resolve issues (as necessary)
- Provide training to production staff on validated work instructions
- Facilitate communication between engineering, manufacturing and quality departments
The Experience You Will Bring
High School Diploma or equivalent required
Bachelor’s Degree in Engineering; OR Associate’s Degree with 6+ years relevant experience required
Technical knowledge in injection molding, product development and medical devices required
- Experience and working knowledge of major quality systems such as: GMP, ISO 9001, ISO13485 required
What Will Put You Ahead
- Experience and working knowledge of 21 CFR Part 820 preferred
- Lead auditor certification or equivalent internal audit experience preferred
- 3+ years’ experience with quality systems in medical device manufacturing environment preferred
- 3+ years’ leadership experience preferred
- 5+ years’ experience drafting medical device validation documents preferred
About Phillips-Medisize, LLC…
Phillips-Medisize, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device and specialty commercial markets.
Visit us: www.phillipsmedisize.com
Phillips-Medisize History: www.phillipsmedisize.com/about-us/history
Salary and Benefits Commensurate with Experience.
Equal Opportunity Employer.
Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test.
This employer uses E-Verify. Please visit the following website for additional information: www.kochcareers.com/doc/Everify.pdf