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Quality Manager- Aurora- Medical Devices

Company: Michael Page
Location: Aurora
Posted on: October 10, 2021

Job Description:

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

*Description*

* Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established company, international (ISO), and governmental regulatory standards and agency guidelines, and to ensure customer satisfaction.

* Act as the Quality Systems Management Representative for the site.

* Maintain compliance and effectiveness to Quality Management System.

* Represents the business/site to outside customer audits. Facilitates (with the VP of Quality/RA) any regulatory audits.

* Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance, and then assist the organization in driving implementation.

* Develops and directs quality programs involving methods, devices and controls.

* Maintains quality through internal and external inspection of raw materials and finished items purchased and production operations and processes.

* Determines and establishes assigned Quality organizational structure and supervisory relationships. Coaches, develops and mentors Quality employees.

* Collaborates with cross-functional colleagues to ensure achievement of standards and regulations

* Bachelor's degree

* 5+ years in quality or engineering

* Experience in managing teams

* Regulatory experience in the medical device space

* Working knowledge of 21 CFR

* Working knowledge of ISO 13485

Our client is a global medical device manufacturer and distributor that specializes in precision machining and quality. They seek a Quality Manager to oversee quality production before their devices are shipped out directly to medical facilities.

* Base salary between 110k and 130k (depending on experience)

* 10% bonus paid out annually

* 4% 401k match

* Tuition reimbursement

* 80 hours PTO per year plus 10 holidays

Keywords: Michael Page, Aurora , Quality Manager- Aurora- Medical Devices, Other , Aurora, Colorado

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