Avantik is actively seeking an experienced Quality Assurance Manager to join our growing team. The Quality Assurance Manager will own responsibility for developing/building, implementing and managing the QMS system and all quality areas for Avantik, which is a medical device distributor and field service provider.

Responsibilities:

• Develop, implement, manage and document a quality management system in conjunction with FDA requirements under CFR 21 Part 820.
• Initial focus of the QMS system will be on our imported consumables, followed by our rebuilt medical equipment and field service.
• Establish and execute internal quality audit processes
• Develop, document and institute recall procedures.
• Create SOP’s for the retention of quality records, device history records and overall record retention.
• Handle both customer and supplier complaints and reporting, including CAPA and SCAR documentation.
• Participate in product development processes and conduct quality reviews.
• Review and maintain supplier and manufacturer quality, including new vendor approvals.
• Develop and maintain key vendor quality KPI’s and scorecards.
• Coordinate all aspects of the regulatory process and approvals.
• Monitor corporate-wide compliance with quality standards.
• Train Avantik staff on SOP compliance as required.
• Ensure labeling and packaging requirements are met and consistent.
• Serve as lead contact for all communications with FDA.
• Prepare for and lead customer quality assurance audits.
• Prepare and send customer communications as needed e.g. quality control letters Complete and respond to customer survey requests.
• Develop and report on Quality KPI’s.
• Serve as the Avantik “Quality Champion” to promote a culture of quality at all points in the Value Stream.
• Review performance breakdowns in all departments, coordinate improvement efforts of Field service recall visits. Review and help to improve shipping errors, order processing errors, product non-conformances, equipment warranty failures and any other customer complaints.

Qualifications:

• A minimum of 8-10 years’ experience in the quality arena, medical device experience strongly preferred
• Expansive knowledge, experience and understanding of FDA requirements under CFR 21 Part 820 and/or ISO 12485:2016.
• Experience and knowledge of products subject to FDA 510(K) regulations a plus.
• Experience developing Quality Systems from the ground up.
• BA, BS Degree or higher.
• Experience with Quality Control in distribution environments.
• Experience working closely with new product development teams.
• Experience in developing policy and procedure and carrying through to implementation.

Avantik is an integrated medical products and services companydelivering superior quality instruments, reagents, consumables, and service tothe anatomic pathology market consisting of hospital, reference, and physicianoffice laboratories in the US.

Our experienced team and consultative partnerapproach integrates consumables, service, equipment, and education so that labsfocus on what matters most - ensuring everything is under control in theirlaboratory to deliver fast and accurate diagnoses.

We offer competitive compensation, bonusprograms, medical insurance (company covers 85% of the cost), dental and visioninsurance, 401K (with a match), tuition reimbursement, and more.