The Quality Assurance (QA) Technician provides critical support for production, purchasing, and product development to ensure all products meet regulatory and customer standards. You will be responsible for reviewing test data, managing raw material release, and leading investigations into non-conforming materials.
Core Responsibilities
- Release & Inspection: Review device history records, CoAs, and test data to release finished goods and raw materials.
- Compliance: Conduct internal audits and ensure all operations align with 21 CFR (FDA) and SQF standards.
- Investigations: Lead non-conforming material (NCM) investigations and draft comprehensive disposition reports.
- Training: Develop and mentor QA Lab Techs and production associates on quality procedures and safety protocols.
- Continuous Improvement: Oversee incoming inspection and skip-lot programs; provide data-driven insights for operational issues.
Key QualificationsCategoryRequirementEducationHS Diploma required; Associate/Bachelor’s in Life Science/Technical field preferred.Experience5+ years in Quality, Lab, or Manufacturing environments.TechnicalProficiency in MS Office; strong knowledge of FDA 21 CFR and SQF.Soft SkillsStrong problem-solving, leadership, and the ability to work with limited supervision.Physical & Environmental Demands
- Environment: Balanced between office and production floor (occasional noise >85db and temp variations).
- Physical: Frequent standing/walking; ability to lift up to 50 lbs occasionally.
- Schedule: Monday – Friday | 8:00 AM – 4:00 PM.
Commitment to Values
This is a Safety-Sensitive position. Candidates must demonstrate a commitment to core values of Renew, Respect, Integrity, Teamwork, and Excellence, ensuring all work is performed in a manner that protects the safety of the team and the consumer.
Job Type: Full-time
Pay: $34.00 - $36.00 per hour
Expected hours: 40 per week
Work Location: In person