Manager, Supplier Quality Engineering

Job Overview

Lead the supplier quality team and coordinate efforts to evaluate, select, qualify, rate, monitor and improve supplier quality.

Job Responsibilities and Essential Duties

• 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.

Minimum Requirements

• 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.

Required Knowledge, Skills and Abilities

• 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).

Supervision/Management of Others

• Supervisory Skills - The ability to coach, develop and motivate associates to optimize team effectiveness.
• Ability to impact team morale, sense of belonging and participation.

Internal and External Contacts / Relationships

• Various

Quality Requirements

• 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.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Duties are performed in an office environment.

Salary will be 115K - 145K annually (depending on experience) with 15% STIP

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