We’re looking for a hands-on Quality & Regulatory Manager who leads from the front. The ideal candidate brings medical device manufacturing and ISO 13485 experience, strong technical problem-solving and statistical skills, and the ability to work alongside the team to get things done. Experience with Cp/Cpk, DOE, validation documentation, root cause analysis, and continuous improvement is highly valued, with plastics injection molding experience a plus. Lean Six Sigma Green Belt or higher preferred. This is an excellent opportunity for a true “working manager” who enjoys balancing leadership with hands-on technical involvement.
We’re looking for a hands-on Quality & Regulatory Manager who leads from the front. The ideal candidate brings medical device manufacturing and ISO 13485 experience, strong technical problem-solving and statistical skills, and the ability to work alongside the team to get things done. Experience with Cp/Cpk, DOE, validation documentation, root cause analysis, and continuous improvement is highly valued, with plastics injection molding experience a plus. Lean Six Sigma Green Belt or higher preferred. This is an excellent opportunity for a true “working manager” who enjoys balancing leadership with hands-on technical involvement.
KEY ACCOUNTABILITIES: (The broad spectrum of items that the role is ultimately held accountable for at the end of the day. Results.)
QMS compliance and audit readiness to ISO 13485 and 21 CFR Part 820 (QMSR)
Continuous improvement project portfolio with measurable, sustained results
Reduction in scrap, rework, customer complaints, and cost of poor quality
Customer quality performance, scorecards, and customer relationships
CAPA, NCR/MRB, complaint, and SCAR effectiveness and on-time closure
New-product launch quality: APQP, PPAP, and validations (IQ/OQ/PQ)
Inspection and metrology programs
Quality KPIs and data-driven decision making
Quality team leadership, development, and accountability
KEY RESPONSIBILITIES: (The finer details of what the role is assigned for the day-to-day activities on the job. Tasks to support results.)
Quality System and Compliance
Own, maintain, and continuously improve the site QMS to ISO 13485:2016 and 21 CFR Part 820 (QMSR)
Lead the site through registrar, FDA, and customer audits; manage the internal audit program and drive timely, effective closure of findings.
Oversee CAPA, NCR/MRB, complaint handling, change control, document control, training, and calibration systems.
Apply risk-based decision making to PFMEAs, control plans, changes, and dispositions; prepare management review inputs on QMS effectiveness.
Continuous Improvement
Lead and sponsor improvement projects using DMAIC and Lean; select projects from complaint, scrap, and KPI data and define charters, scope, metrics, and RACI charts.
Apply statistical tools, including SPC, capability (Cp/Cpk, Pp/Ppk), MSA/Gage R&R, hypothesis testing, regression, and DOE, to drive decisions.
Coach engineers and staff in Six Sigma and root-cause methods (8D, 5 Why, fishbone); mentor Yellow and Green Belt projects.
Sustain gains through control plans, standard work, error-proofing, and visual management.
Customer and Product Quality
Serve as the primary quality contact for customers on technical discussions, quality agreements, scorecards, complaints, SCARs, audits, and change notifications.
Review drawings, specifications, and GD&T with customers and Engineering; resolve tolerance, datum, and measurement-method questions so inspection reflects design intent.
Oversee NPD quality deliverables through Stage-Gate, including DFQ/DFM review, APQP, PFMEA, control plans, FAI, PPAP, IQ/OQ/PQ, and test method validation.
Oversee FAI, in-process, and final inspection, sampling plans, and metrology, including CMM and vision systems.
Partner with Purchasing on supplier approval, performance monitoring, audits, and SCARs.
Leadership
Lead, develop, and hold accountable Quality Engineers, inspectors, and quality staff;…