Manager, Supplier Quality Engineering
- Merrimack, NH
- $115,000-145,000 per year
- Permanent
- Full-time
- Collaborate with the supply chain management team, quality control, engineering and regulatory to establish guidelines for supplier quality and performance.
- Ensures that supplier quality personnel maintain the required skill level to address compliance issues and to understand the technical aspects of compliance.
- Responsible for ensuring that training is completed for direct reports and database is up to date.
- Develop risk based programs for supplier qualifications and supplier performance and productivity improvement.
- Develop strategy for continuous supplier quality improvement.
- Create benchmarks to measure department performance.
- Create reports that measure and track supplier quality performance to identify opportunities for supply chain improvements.
- Oversees supplier rating program.
- Participates in team project meetings for new product development.
- Plays a major role in the supplier selection process, evaluation of potential suppliers and the supplier qualification process.
- Manages supplier audit program and participates as needed.
- Oversees audit/assessment of current and future suppliers ensuring they are compliant with requirements.
- Oversees validations and qualifications of supplier facility to qualify manufacturing processes and overall quality of part/component manufacturing.
- Contributes to team effort by accomplishing related tasks as necessary.
- Bachelor Degree in Engineering, Scientific or related discipline, or equivalent work experience.
- A minimum of six progressive years' experience in a supplier quality role or equivalent position.
- Experience in the areas of lot acceptance sampling methodologies, MSA/GR&R, SPC and other statistical techniques.
- Demonstrated knowledge of business impact, compliance issues and risk management.
- Good project management ability.
- Familiarity with CAPA Systems and working knowledge of applicable regulations and standards such as FDA QSR, ISO, ROHS, WEE, REACH and MDD.
- Audit experiences a must. Previous supervisory experience required.
- Six Sigma and ASQ certification (CQE, CQA) highly desired.
- Strong skills in negotiation and influencing decision makers, as well as judgment, tact and leadership ability.
- Strong computer skills with proficiency in MRP systems.
- Experience with an ERP system and/or ERP implementations and Oracle would be a plus.
- Excellent working knowledge of MS Office (Word/Excel) and a statistical based software package (Minitab preferred).
- Supervisory Skills - The ability to coach, develop and motivate associates to optimize team effectiveness.
- Ability to impact team morale, sense of belonging and participation.
- Various
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
- Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
- Attend all required Quality & Compliance training at the specified interval.
- Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
- Ensures environmental consciousness and safe practices are exhibited in decisions.
- Duties are performed in an office environment.
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement