Quality Manager Medical Device Manufacturing

Quality Manager, Medical Device Manufacturing

Location:

Irvine / Orange County, CA

Company:
Dyna Flex Technologies

Employment Type:

Full-time

Compensation:
Competitive base salary, bonus opportunity, and stock option eligibility based on experience

Dyna Flex Technologies is a growing ISO 13485 medical device contract manufacturer specializing in catheter components, extrusion, braiding, reflow, balloon processing, and complex medical device assemblies. We support medical device companies from development through commercial production and work closely with customers on technically challenging programs.

We are looking for a hands‑on Quality Manager to lead our quality function and strengthen quality discipline as the company continues to grow.

The Quality Manager will be responsible for leading both Quality Assurance and Quality Control activities in a medical device manufacturing environment. This role requires someone who can manage the quality system, support customer and regulatory audit readiness, work directly with production and engineering, and drive practical resolution of quality issues.

This is not a purely administrative or paperwork role. The right person must be comfortable working on the manufacturing floor, reviewing records, supporting inspection activities, driving CAPA and NCMR closure, and helping the organization maintain strong compliance and product quality.

• Lead daily Quality Assurance and Quality Control activities across manufacturing operations.
• Maintain and improve the ISO 13485 quality management system.
• Support customer audits, internal audits, supplier audits, and regulatory audit readiness.
• Manage CAPA, NCMR, deviation, complaint, and investigation activities.
• Oversee incoming inspection, in-process inspection, final inspection, and lot release discipline.
• Ensure DHR, DMR, product specifications, procedures, work instructions, and quality records are accurate and properly maintained.
• Work closely with manufacturing and engineering to identify root cause, implement corrective actions, and improve process controls.
• Support process validation, test method validation, IQ/OQ/PQ, and related quality documentation.
• Manage supplier quality activities, including supplier qualification, monitoring, nonconformance follow-up, and corrective actions.
• Review and approve quality documentation, change orders, inspection records, and manufacturing records as needed.
• Train, coach, and develop quality team members.
• Drive practical continuous improvement while maintaining compliance with medical device quality requirements.
• Communicate quality risks, priorities, and required actions clearly to leadership and cross‑functional teams.

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical field preferred.
• 7+ years of medical device quality experience.
• 3+ years of experience leading or managing quality personnel preferred.
• Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Experience with CAPA, NCMR, complaint handling, internal audits, supplier quality, DHR/DMR, document control, inspection, and lot release.
• Experience supporting customer audits and audit response activities.
• Experience in catheter, extrusion, tubing, balloon, assembly, or contract manufacturing environments is strongly preferred.
• Ability to work in a hands‑on, fast‑paced manufacturing environment.
• Strong problem‑solving skills and ability to drive issues to closure.
• Strong communication skills with the ability to work directly with production, engineering, supply chain, customers, and leadership.
• ASQ certification, lead auditor training, or regulatory experience is a plus.

The ideal candidate is structured, hands‑on, practical, and comfortable enforcing quality discipline in a growing medical device manufacturing environment. We are looking for someone who can own the quality system while also staying close to daily operations.

This person should be able to identify gaps, prioritize risks, drive follow‑through, and help build a stronger quality culture without creating unnecessary bureaucracy.

• Broad ownership of the quality function.
• Direct visibility with executive leadership.
• Opportunity to work on complex catheter and medical device manufacturing programs.
• Growing company environment with meaningful impact.
• Stock option eligibility based on experience and role fit.