Manager, Quality Operations (CDx/GMP)
About The Position
The Quality Operations Manager, Quality Operations leads a team responsible for execution and oversight of production and process control quality activities within an IVD medical device manufacturing environment. This role combines people leadership with strong technical and operational accountability and ensures that quality engineering activities are executed effectively, consistently, and in compliance with FDA QMSR, ISO 13485, and GMP expectations. The role is expected to make timely quality decisions, manage escalations, and maintain a high state of operational readiness.
Requirements
- Experience in an IVD medical device manufacturing environment.
- Knowledge of FDA QMSR, ISO 13485, and GMP expectations.
- People leadership skills.
- Strong technical and operational accountability.
- Ability to make timely quality decisions.
- Ability to manage escalations.
- Ability to maintain a high state of operational readiness.
Nice To Haves
- Relevant skills
- Training
- Experience
- Education
- Certifications obtained
Responsibilities
- Leads a team responsible for execution and oversight of production and process control quality activities within an IVD medical device manufacturing environment.
- Combines people leadership with strong technical and operational accountability.
- Ensures that quality engineering activities are executed effectively, consistently, and in compliance with FDA QMSR, ISO 13485, and GMP expectations.
- Makes timely quality decisions.
- Manages escalations.
- Maintains a high state of operational readiness.
Benefits
- Day 1 Medical, supplemental health, dental & vision for FT employees who work 30+ hours
- Best-in-class well-being programs
- Annual, no-cost health assessment program Blueprint for Wellness®
- healthyMINDS mental health program
- Vacation and Health/Flex Time
- 6 Holidays plus 1 "MyDay" off
- FinFit financial coaching and services
- 401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service
- Employee stock purchase plan
- Life and insurance, plus buy-up option
- Flexible Spending Accounts
- Annual incentive plans
- Matching gifts program
- Education assistance through MyQuest for Education
- Career advancement opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
