Director of Quality Assurance



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Job Type




Salary Range

Based on Experience

No. of Openings


Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435



Job Description

Manpower Engineering has partnered with a growing twin cities company that develops and manufactures minimally invasive neurovascular and cardiovascular products. The organization is currently hiring for a Director of Quality Assurance to lead quality across the organization.


The Director of Quality Assurance is responsible for the strategic direction, planning, and deployment of the company quality functions to achieve corporate objectives while ensuring full compliance to FDA QSR (21 CFR 820), and ISO 13485:2016 requirements. The position collaborates with senior management staff and all personnel throughout the company on a strategic level to anticipate and prepare for current and future Quality needs.


* Provide direction and oversight for the ongoing management of the Quality System.

* Prepare the company for future changes in regulations and standards.

* Support the Product Development function by appropriate allocation of Quality Engineering resources for the purpose of product development and field support.

* Collaborate with the operations leadership team to develop and implement strategic supplier management, including selecting, approving and maintenance of suppliers, including supplier quality plans, process plans and validations.

* Direct Quality Control and Quality Assurance functions to ensure product quality and continuously improve both product and process quality.

* Act as primary contact for FDA and Notified Body quality system audits.

* Support the Regulatory function by implementing appropriate compliance strategies.

* Provide systems for the collection, analysis and communication of quality data.

* Oversee Corrective and Preventative Action (CAPA) system and ensure overall health and adequacy.

* Responsible for planning, scheduling, and preparing Management Review based on established frequency schedule.


* 7+ years of work experience in quality engineering within related medical device environment required

* 3+ years of experience in management required

* Lead Auditor (ISO 13485) certification

* Formal Management and Leadership training desirable

* Ability to facilitate the development of direct reports

* Ability to manage tight timelines and budgets, and changing/conflicting priorities

* Experience leading quality organizations supporting, product development, purchasing and/or production functions

* A strong background in quality systems, including implementation of ISO 13485, technical files, and FDA QSR compliant systems

* Additional experience in operations, engineering, supplier relations, inspection and test, auditing, product development required