Director of Quality

Description

PMC is offering an opportunity for a results-oriented quality leader to join a high-trust leadership team building for growth.

Who is PMC SMART Solutions?

PMC, as a privately held, globally-recognized, award–winning contract manufacturer that provides life‑saving medical devices & safety‑enhancing automotive components to a broad base of international, market‑leading OEMs & Tier One customers. Tier One customers, including Medtronic, Stryker, Baxter, Cook Medical, Zimmer Biomet, Olympus, Bosch, Continental & others.

PMC offers services from design for manufacturability & program management through injection molding, full assembly, packaging & sterilization management, focusing on precise‑tolerance, intricate devices & components. For its medical customers, PMC functions under ISO 13485 certification, FDA registration & operates state-of-the-art, certified Class 8 (100,000) clean rooms. PMC maintains an IATF-16949 certification in support of our automotive business.

PMC is a certified Women‑Owned Business Enterprise, offering a comprehensive range of services while supporting global OEMs’ supplier diversity goals.

What would you look forward to in this role?

• Establishing & communicating a vision for world‑class quality for our organization
• Leading the development of people, processes & systems to realize this vision
• Collaborating with all the other key leaders in our organization to achieve our organization’s goals
• Growing as a leader, benefit ting from the “shared success” of achievement & surrounding yourself with the team needed for long‑term growth & prosperity

What key responsibilities would you assume in this role? Regulatory Compliance & Systems

Owns & maintains the Quality Management System (QMS), ensuring alignment with ISO, IATF, & FDA standards

Owns & administers document control system, ensuring accurate & complete records

Owns & oversees all external & internal audits with all stakeholders

Operations Quality

Owns & oversees the timeliness, accuracy & compliance of major obligations such as (not limited to):

• Device History Records (DHR)
• Controlled environment standards
• Sterilization management
• Inbound component quality
• Shop floor quality processes- control plans, operator training
• In‑process & finished goods testing
• Return Goods Authorizations (RGA) & Return Material Authorizations (RMA)
• Root cause analysis & resolution strategy for escalated quality issues
• Metrology lab

Leadership, Management & Accountability

Builds & develops a high‑performing team by recruiting, mentoring, & coaching managers across all quality functions.

Establishes clear performance expectations, priorities, & accountability measures aligned with PMC’s core values.

Conducts regular performance updates, tracking KPIs, such as customer‑facing quality events, corrective action closure, & team readiness.

Leads quality team participation in EOS leadership practices, including weekly L10 meetings & quarterly resets.

Strategy & Planning

Partners with the COO to define the vision, growth strategies, & cultural priorities for Quality.

Develops & manages departmental budgets / decisions around CAPEX, technologies & equipment.

Ensures the Quality function is in alignment with organizational goals & positioned for future growth.

Project Launch Quality

Collaborates with project teams to define quality requirements for new product launches

Requirements What is needed to thrive in this role?

• A minimum of 10 years in quality assurance or related fields, including a minimum of five (5) years’ experience in a quality leadership role
• Proven expertise in global medical device regulations & quality for Class II medical devices
• Thorough knowledge of 21 CFR 820 & ISO 13485 required
• Deep knowledge of global regulatory frameworks (FDA QSR, ISO, GMP) & proven track record of leading audits, submissions, & agency interactions
• Bachelor’s degree in Engineering/Technical field required
  - Business Acumen or Degrees also a plus
• Competency in Microsoft Office software use (especially Word, Excel & PowerPoint) is required
• Demonstrated ability to lead a team – beginning with exceptional leadership of self!
• Demonstrated experience & success with customer‑facing problem solving, with a deep analytical toolkit, & utilizing an approach that builds trust
• A highly organized, detail‑oriented, self‑motivated & collaborative work style is essential for success
• A strong bias for action & self‑initiative towards achieving the most important commitments & expected results

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