QUA Technician

Quality Assurance Specialist

Supports the Distribution Quality team by applying the Quality Body-of-Knowledge for post-production quality assurance programs, policies, processes, procedures and controls for medical devices, drug/device combination products, filtration products, and purchased finished goods. Works with moderate work direction, and can identify issues/problems but may need assistance in resolving. Driving improvement opportunities to proactively ensure internal distribution center and 3rd party Distributor compliance to all applicable internal, domestic, and international quality regulations and competent authority requirements, including but not limited to, US 21 CFR 210, 211, and 820, ISO 13485, ISO 14971, EU MDR, Health Canada, ANVISA, COFEPRIS, MHRA, TGA, NMPA, PMDA, etc.

Executing projects and efforts to ensure area and country-level quality system and competent authority compliance for distribution center product quality assurance, material storage requirements, local language over-labeling, product ship holds, and product release Partnering with the Operations and Supply Chain organizations to ensure effective oversight of globally-located internal distribution centers in order to drive quality and compliance, reduce risk, improve processes, and reduce waste using the quality improvement tools of process control & monitoring, structured problem solving, and trend analysis with timely and effective signal resolution Supporting appropriate quality management oversight mechanisms for a broad network of global 3rd party Distributors who provide a variety of services in countries where an export model is leveraged N/A Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.