Director Quality Operations Jobs in Howell, MI (NOW HIRING)

• Provide strategy and leadership over Quality Engineering (QE) teams at the Rockford and Linden sites, supporting design transfer/control/assurance, risk management, statistical analysis of data, deviations, complaints, change management, and quality improvement projects.
• Direct oversight and development of Quality Engineers for the Advanced Drug Delivery business segment, assigning them to projects based on technical expertise and project priority.
• Lead the QE team to support new product introduction and technology transfer for product launches, as well as the sustaining of commercialized products.
• Manage overall staffing, reviewing, planning, and administering resource allocation and workload planning for QE staff.
• Serve as subject‑matter expert and process owner for design control and risk management procedures within the Quality Management System, including a risk management program aligned to ISO14971.
• Oversee and approve investigations including calibration out‑of‑spec, laboratory or environmental monitoring product impact investigations.
• Approve site supplier nonconformances and supplier‑related quality metrics.
• Process owner for Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection Plans and techniques, GR&R, test requirements, and Test Method Transfer/Validation.
• Conduct technical evaluation of change controls, risk assessment, and implementation of risk mitigation strategies.
• Provide high‑level guidance on complex design validation and verification (V&V) strategies, sampling plans, and root‑cause investigations for design failure.
• Oversee the feedback loop between Post‑Market Surveillance (complaints) and internal or external design assurance teams to trigger necessary design changes or CAPAs.
• Act as the final quality approver for major “Stage Gate” transitions, ensuring all design inputs, outputs, and transfer activities are complete and compliant.
• Ensure design assurance strategies align with evolving global standards, including ISO13485 and FDA21CFR820.
• Apply scientific statistical analysis techniques to proactively identify trends, root causes, and implement actions to mitigate recurrence.
• Provide input for statistical assessment of data to drive continuous improvement.
• Support and maintain quality assurance programs, policies, procedures, and controls, ensuring products meet established standards and regulatory requirements.
• Participate in steering committees to guide and influence company focus on new products, customers, and strategic initiatives.
• Prepare reports for company management detailing the status of open projects that support capacity, regulatory, and quality improvement requirements.
• Present quality standards, process flows, inspection plans, and issues internally to stakeholders and externally to clients with confidence and accuracy.
• Ensure the QE team achieves compliance levels and develops actions to sustain performance through metrics and KPIs.
• Support recruitment, coaching, and development of Quality Engineers to achieve excellence and efficiency when programs scale.
• Create a learning culture that enables individuals to reach their maximum potential.
• Manage budget development and periodic projections of spending against budgets, controlling departmental spending.
• Partner with internal teams (Business Unit, Quality, Operations, Engineering, Validation) to achieve company goals.
• Participate in regulatory inspections, customer audits, visits, and conference calls.

• Lead a group of up to ten direct reports across multiple sites.

• College or trade degree required (engineering or related scientific degree).
• Minimum 5+ years of experience in an FDA‑regulated industry, preferably medical device or combination products.
• Proficiency with personal computers, MSOffice, and technical software (ERP and eQMS systems).
• Ability to create, use, and interpret scientific tables, charts, and graphs.
• Advanced computer skills for performing complex tasks across multiple programs.
• Full professional proficiency in speaking, reading, and writing fluently and accurately.
• Analytical ability to conduct effective root‑cause analysis and critical thinking for complex problem solving.
• Excellent organizational, time‑management, and multi‑tasking skills to meet commitments and deadlines.
• Experience in technical writing and utilizing root‑cause analysis tools.
• Lean Six Sigma or other formal process‑improvement skillsets highly desirable.
• Technical knowledge of test method validation, MSA, and medical device processes preferred.

• Base salary range: $108,690–$136,200, plus eligibility for an annual 10% performance bonus.
• Benefits package includes paid time off, health insurance (including dental and vision), a flexible spending account, and a 401(k) plan.

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, equity and inclusion are at the core of our company’s purpose. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity at every level.