What are the responsibilities and job description for the Director of Quality position at PMC Smart Solutions LLC?
Description
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, ZimmerBiomet, 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, benefitting 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
