Regional Supplier Quality Manager at Teleflex in Maple Grove, MN
Position Summary Position is directly accountable for managing Supplier Quality engineering functions across multiple sites in Notrh America & EMEA. The role will include staffing, developing, and managing a Supplier Quality Engineering team to effectively support and execute supplier qualifications, supplier maintenance, quality agreements, supplier auditing, SCARs, and supplier-driven changes. Additionally, this role will drive initiatives for optimization of Quality System deliverables and processes, and foster a positive culture of growth, collaboration, and achievement across the organization. This position can be located in Maple Grove, MN or Chelmsford, MA Principal Responsibilities o Manage, mentor, and develop Supplier Quality Engineering teams at each of the facilities but also as in a Regional context. o Manage teams in support of development and production, including the selection, qualification, and maintenance of suppliers. o Demonstrate expertise and drive compliance with company policies/procedures, ISO 9001, ISO 13485, FDA QSRs, EU MDR, and other applicable standards. o Establish strategic direction for the Regional Supplier Quality group, aligned with Global Supplier Quality strategies and including objective and goal setting. o Assess Supplier Quality Engineering metric performance, and report to leadership teams. o Identify, define, drive, and support strategic initiatives for Supplier Quality Engineering. o Drive continuous improvement in Supplier Quality Engineering systems with a focus on best-in-class processes and procedures that enhance compliance and produce business efficiencies. o Develop and maintain strong relationships and effective lines of communication with internal and external customers, as well as suppliers. o Support internal, external, and customer inspections and Quality System audits, including preparation and direct interaction with auditors. o Partner with New Product Development, Operations, Supply Chain, Microbiology, and Quality Assurance on organizational, procedural, and strategic initiatives and implementation. o Provide guidance to teams through technical, system, and execution challenges. o Partner cross-functionally to scope, staff, support, and prioritize improvement projects. o Engage with Quality Assurance to execute and manage supplier-related non-conforming events. Education / Experience Requirements o BA/BS in Engineering or physical sciences required, master's degree preferred. o Minimum Five years of related experience required. o Three years of experience managing/supervising a team. Specialized Skills / Other Requirements o Ability to coach, direct and develop a high performing team of engineers and technicians. o Ability to structure and direct teams in alignment with cross functional teams. o Establish work direction and supervision of Supplier Quality Engineering staff across all relevant sites. o Experience with quality-related tools including, but not limited to, SPC, DOE, and TMV; experience with various process-improvement methodologies, such as Six Sigma and Lean Manufacturing. o Communicate team and project status to senior management. o Ability to define, organize, and manage individual and team tasks with appropriate prioritization. o Effective verbal and written communication. o Proficient in reviewing, assessing, and advising on technical topics. o Interpersonal skills; working cross-functionally, in a team, and as an individual contributor. o Thorough understanding of design/process/supplier controls, risk management, statistics, and production. o Minimum 3 years' experience with US and international medical device regulations, standards and guidance documents. Including:
o 21 CFR 820 US FDA Quality System Regulations o ISO 13485:
2016 Medical Devices - QMS - Requirements for Regulatory Purpose o MDD 93/42/EEC Medical Device Directive (European) o Regulation (EU) 2017/745 Medical Device Regulations o ISO/IEC 17025:
2017 - General Requirements for the Competence of Testing and Calibration Laboratories o Project Management skills and experience.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Supply Chain & LogisticsEstimated Salary: $20 to $28 per hour based on qualifications.
o 21 CFR 820 US FDA Quality System Regulations o ISO 13485:
2016 Medical Devices - QMS - Requirements for Regulatory Purpose o MDD 93/42/EEC Medical Device Directive (European) o Regulation (EU) 2017/745 Medical Device Regulations o ISO/IEC 17025:
2017 - General Requirements for the Competence of Testing and Calibration Laboratories o Project Management skills and experience.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Supply Chain & LogisticsEstimated Salary: $20 to $28 per hour based on qualifications.
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