Quality & Regulatory Manager

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; define roles and responsibilities using RACI charts. Partner with Operations, Engineering, Tooling, Processing, and Sales to set quality targets, align priorities, and escalate risks. Report quality KPIs to site and executive leadership, manage the department budget, and build a culture of ownership, data-driven problem solving, and recognition.   LMA RESPONSIBILITIES: (Leadership, Management, Accountability)   Responsible for the direction, coordination, performance, and evaluation of all quality assurance employees, in accordance with company policies and applicable laws. Responsibilities include meeting company goals and metrics; interviewing, hiring, and training employees; planning, assigning, and directing work; and appraising, rewarding, and disciplining employees.   QUALITIES FOR SUCCESS: (Seaway Core Values, Education, Training, Certifications, Years of experience, Other skills and abilities, Physical Requirements for the Role, etc.)   Demonstrates Seaway Plastics Core Values We are customer focused We execute We win together We are respectful   Required Bachelor’s degree in engineering or a related technical discipline. 4+ years of quality and/or engineering experience in regulated manufacturing, including 2+ years leading teams. Strong working knowledge of ISO 13485 and 21 CFR Part 820 (QMSR), with experience hosting registrar, FDA, or customer audits. Six Sigma Green Belt or higher, with a track record of leading improvement projects to measurable results. Proficiency in applied statistics and Minitab or similar software. Strong GD&T and drawing interpretation skills and working knowledge of metrology. Confident customer-facing communicator, able to lead technical discussions and present to customers and executives. Leader who makes sound decisions, delegates appropriately, coaches others, and manages projects with clear charters, timelines, and RACI charts.   Preferred Plastic injection molding and medical-device contract manufacturing experience, including cleanroom operations. Six Sigma Black Belt; ASQ CQE, CMQ/OE, or CQA; ISO 13485 lead auditor. Prior experience as a Quality Engineer and/or Manufacturing or Process Engineer.   Physical Demands Sit, stand, and walk throughout office and manufacturing areas. Use computers and office equipment for extended periods. Perform visual inspections requiring close attention to detail. Occasionally bend, reach, and lift up to 25 lbs. Communicate effectively with employees, auditors, and regulatory agencies