What are the responsibilities and job description for the Quality Assurance Manager position at Astrix?
Join a fast-paced, rapidly growing regulated distribution environment managing a high-performing team, collaborate cross-functionally, and make a direct impact on product integrity and operational excellence.
Pay: $85k
Key Responsibilities:
- Lead and develop the Quality Assurance team (6-10), ensuring compliance with regulatory and company standards.
- Provide training, coaching, conduct internal audits, manage CAPAs & perform risk assessments
- Ensure adherence to Good Manufacturing and Distribution Practices.
- Work with the Global Quality Operations along with with sales, marketing, procurement, planning, operations customer service, and other teams to resolve quality concerns.
- Analyze quality data, implement process improvements, and drive cost-effective quality initiatives.
- Maintain documentation control, oversee change management, and ensure training compliance.
- Ensure compliance with local and international regulatory requirements to meet GMPs and GDPs standards.
Qualifications:
- Master's/Bachelor’s degree in Quality Assurance, Engineering, Life Sciences, or a related field.
- 4-6 years of experience in quality assurance within a regulated industry (medical devices, pharmaceuticals, or life sciences).
- Experience with ISO 13485 and FDA regulations,
- Strong leadership, problem-solving, and cross-functional collaboration skills.
- Proficiency in Microsoft Office, ERP systems (e.g., D365), and quality management tools preferred.
Benefits
This is a full time direct hire opportunity not through a an agency or contract.
Will be eligible for:
- Vision, Dental, and Healthcare
- 401k is 50 cents to the dollar up to $8k. If you put in $8k, matches at $4k, if you put in $2k matches at $1k
- 3 weeks PTO plus 6 sick days 2 personal days plus 10 major holidays
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
Salary : $85,000 - $95,000
