Quality Manager

About PathRight Medical

PathRight Medical designs, manufactures and sells medical devices for men's health, including the RestoreX penile traction system. We build and mold our devices in house in Utah and sell them in the US and international markets. We are growing our quality department and are hiring an experienced quality leader to own our quality system, manufacturing quality and supplier quality.

The role

You will be one of two senior quality peers reporting to the CTO and Head of Quality. You own the quality system and its governance, manufacturing and molding quality approval, and supplier quality. Your peer owns regulatory affairs, design and post-market quality, and training. You work directly with manufacturing, molding, purchasing and R&D: they write and run their processes, and you set the requirements, approve their documents and keep the system effective.

What you will do

Quality system and governance

• Own the quality policy, quality objectives and KPIs, and the quality manual and QMS process map
• Serve as the appointed management representative; keep the QMS compliant with ISO 13485, FDA QMSR (21 CFR 820) and ISO 14971
• Run the SOP and work instruction program, document templates, periodic review, records retention and data integrity checks in our eQMS (Qualio)
• Prepare management review, analyze quality data and trends, and report cost of quality

Audits

• Plan and conduct internal audits and lead external audits by FDA and our notified body (BSI)
• Keep the company ready for FDA inspections, records requests and unannounced notified-body audits
• Track audit findings to closure with the process owners who implement them

CAPA, deviations and nonconforming product

• Own the CAPA, SCAR and deviation programs: root cause analysis, implementation and independent verification of effectiveness
• Run NCMRs and the Material Review Board; trend nonconformances and escalate to CAPA

Manufacturing and molding quality

• Approve manufacturing and injection molding SOPs, work instructions, forms and process validations (IQ/OQ/PQ)
• Own the inspection program: receiving, in-process and final inspection criteria, inspector qualification, first-article inspection and measurement system analysis
• Hold final product release authority and review device history records
• Own the calibration program, control plans, sampling plans and revalidation triggers
• Set requirements for cleanliness, ESD, storage and facility controls, and audit the records

Supplier quality

• Own the approved supplier list, supplier audits, SCARs, quality agreements and supplier re-evaluations
• Control critical suppliers and outsourced processes such as anodizing and laser marking
• Set the purchasing rules Purchasing follows: released specifications only, approved suppliers only

Distribution and design transfer

• Approve distribution, storage and traceability controls so a recall can reach every customer
• Lead quality for design transfer of new products

What you bring

• At least 5 years of quality experience in medical device manufacturing; 10 or more years preferred
• Working knowledge of ISO 13485, FDA 21 CFR 820 (QMSR) and ISO 14971
• Hands-on experience running CAPA, nonconformance and MRB, internal audits and supplier quality programs
• Experience hosting FDA inspections or notified-body audits
• Process validation (IQ/OQ/PQ) and inspection experience, ideally including injection molding
• Statistics for quality: sampling plans, gauge R&R, process capability
• Bachelor's degree in engineering, a physical science or a related field
• Able to work independently, set priorities and hold other departments to quality requirements without managing them

Preferred

• ASQ CQE, CQA or CMQ/OE certification; ISO 13485 lead auditor training
• Experience with an eQMS such as Qualio
• Experience with EU MDR, MDSAP or electronics assembly (IPC-A-610)

Pay: $110,000.00 - $130,000.00 per year

Work Location: In person