Quality Engineer needed for a amazing opportunity in the Clinton, MA area with a high growth company. The Quality Engineer would be responsible for ensuring facility objectives are met by providing direction and leadership for all location quality functions through improved communication and systems utilized by external and internal customers and suppliers. Apply now for immediate consideration!
location: Clinton, Massachusetts
job type: Permanent
salary: $80,000 - 95,000 per year
work hours: 8am to 5pm
- Implement systems and procedures that assure compliance with Quality Standards
- Develop and implement statistical incoming and in-process sampling/control plans
- Manage the Supplier qualification process; lead corrective actions relating to supplier performance; improve process for supplier data submission to reduce internal inspections
- Leads investigation of out of specification situations to determine if there is impact to released product. Writie technical reports in support of NCMR investigations, CAPAs and containment activities used to support recall or no recall decisions.
- Use statistics to assess product performance data, solve complex manufacturing quality problems and support validation strategies (Cpk, SPC, t-tests, OC Curves, sample size, Minitab).
- Participate in initial process development, Design for Manufacturing and Design for Assembly phases. Develops validation templates.
- Interfaces with engineering, operations, customer, and vendor representatives to ensure all requirements are met.
- Assist with third party and FDA quality audits as needed.
- Responsible for leading change control teams to ensure changes to processes and equipment do not impact product quality or the validated state.
- Facilitate communication between engineering function, manufacturing, and quality
- A communication liaison between the customer and manufacturing facility
- Some travel to other facilities may be required to support business needs
- Some programs may have vision requirements
- Minimum six (6) years quality/regulatory experience
- Minimum Three (3) years auditing experience
- Understanding of the project development process, associated terminology, and quality system requirements
- Ability to effectively present information and respond to questions from group of managers, sales, and customers
- Strong communication (verbal and written), teamwork and organizational skills
- Ability to identify problems, and develop and implement actions to resolve them
- Demonstrable track record of planning activities with contingency actions
- Quality Engineer, Plastic Injection Molding, Medical Device, Audits, cGMP, CAPA, Statistical Analysis
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.