Manager, Supplier Quality Assurance

Description

Job Title: Manager, Supplier Quality Assurance

Supervisor/Manager Title: Senior Manager, Quality

Job Description Summary:

• As a Supplier Quality Assurance Manager, you'd be responsible for ensuring the quality of supplied components, materials and services, leading supplier audits, managing supplier performance, and driving continuous improvement within the supply chain to meet regulatory and quality standards.

Job Responsibilities:

Supplier Qualification and Management:

• Lead supplier qualification activities, including audits and assessments, to ensure suppliers meet JVT’s quality standards and regulatory requirements.
• Manage supplier performance, identify areas for improvement, and implement corrective actions.
• Develop and maintain supplier quality agreements and documentation.

Supplier Audits:

• Conduct/co-ordinate supplier audits to assess their quality management systems and processes.
• Identify and address non-conformances and areas for improvement.
• Prepare and present audit reports to management.
• Ensure that suppliers adhere to applicable quality standards, procedures, and regulatory requirements.
• Support the development and implementation of quality control plans and procedures.
• Participate in internal and external audits.

Continuous Improvement:

• Identify and implement opportunities for continuous improvement in supplier quality and performance in addition to Receiving inspection, risk-based sampling plan for inspections, associated equipment needs/upgrades.
• Leads, manages, and develops the Quality Control - Receiving Inspection (QC-RI) team.
• Utilize data analysis and statistical tools to monitor supplier performance and identify trends.

Communication and Collaboration:

• Communicate effectively with internal and external stakeholders, including suppliers, engineers, and management.
• Collaborate with cross-functional teams to address quality issues and improve processes.
• Ensure that the QC-RI team is trained and resourced to provide a compliant service that enables timely valve disposition.
• Utilize continuous improvement techniques in conjunction with R&D and RA to streamline and simplify the incoming inspection process.
• Ensure ongoing consistency of QC standards for RI between all inspectors and between sites.
• Lead change control activities to support compliance and site improvements.
• Support risk analysis, in particular, PFMEA review and ongoing risk assessment associated with change and non-conformance.
• Track performance and performs quality trend analysis for quality operations; develops scorecards and key performance indicators to drive continuous improvement.
• Utilize lean manufacturing, error proofing and continuous improvement principles.

Other Business Support:

• Supports receiving inspection process as required and especially for items with secondary inspection requirements.
• Support QE as required to ensure that all supplier (and in-house as needed) processes are validated, that equipment is qualified, calibrated and maintained per the Validation Master Plan (VMP), applicable procedures and regulatory requirements.
• Perform other related duties or tasks assigned by the leadership.

Qualifications

Required Education and Experience:

• A Bachelor of Science degree or equivalent in a technical discipline (e.g., Biology, Chemistry, Microbiology, Engineering).
• Minimum of 1 years’ experience within a management or supervisory role.
• Minimum of 3 years’ hands-on experience in a supplier quality role within a Manufacturing environment within the medical devices or related industry.
• Working knowledge of European and US Quality System requirements (ISO 13485 and 21CFR820). 
• Working knowledge of contamination control and monitoring of controlled environments; process validation; nonconformance resolution; CAPA; risk management and continuous improvement.
• Thorough knowledge of state-of-the-art inspection and quality inspection and quality engineering/assurance techniques and principles.
• Working knowledge and experience of Lean principles and 6-sigma tools.
• Proven track record transforming processes, systems and teams and driving change initiatives.

Skills and Abilities Required for This Job:

• Management and people leadership skills.
• Demonstrated ability to work effectively and collaboratively within cross-functional teams.
• Strong verbal and written communication & presentations skills; comfortable presenting to all levels of an organization.
• Excellent problem-solving skills.
• Results focus, attention to detail, process-oriented with ability to prioritize work in line with business objectives.
• Strong analytical skills, strategic thinking capability and sound business judgment.
• Experienced with Microsoft Office programs and, ideally, with statistical packages such as Minitab.
• Self-motivated and ability to conduct hands-on work with a high degree of independence.

Salary : $127,000 - $135,000