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Sr Mgr, Quality Assurance

Performance Health | Cedarburg WI 53012 USA | Full Time | Posted: 09/20/2019

Job Descriptiontop

The Sr. Manager, Quality Assurance leads all Corporate Quality Assurance activities for manufacturing and contract manufactured product. Assures quality systems at all manufacturing & contract manufacturing locations meet medical device regulatory requirements for where the product is sold in the US and internationally.

To perform this job successfully, an individual must be able to perform each essential job duties satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential Job Duties & Responsibilities
Site responsibility for developing & maintaining Quality Management System in compliance with ISO 9001, ISO 13485, 21 CFR 201 & 211, 21 CFR 820 and other regulatory/quality standards as applicable (Role serves as site Quality Management Representative)
Lead ISO and FDA site audits and inspections and maintain site medical device registrations and certifications
Identify and drive significant product and process Quality improvements via establishing effective cross functional relationships and use of proven data analysis tools/methodoligies such as 6 Sigma, Lean, DOE, FMEA, and Gage R&R
Ensure appropriate analytical testing/measurement equipment and methodologies are utilized in quality assessment; serve as a metrology resource
Manage process verification and validation activities according to FDA and other global regulatory agency requirements
Drive timely investigation of customer complaints in identifying potential cause(s) and determining if additonal investigation and Corrective Action is required via the CAPA process
Performs other duties as assigned


Job Qualification

Bachelor of Science degree in Engineering or other related technical field
5 years of experience within a medical device regulated industry (e.g. FDA, ISO)
Demonstrated understanding of data-driven electronic Quality data analysis tools such as Minitab & Excel pivot tables, and problem solving methodologies such as 6 Sigma, and SPC
Strong knowledge and understanding of FDA 21 CFR Part 803, 806, & 820, ISO 14971 and ISO 13485 regulatory/quality standards as pertaining to Design & Production controls
Ability to travel up to 10% of the time, including overnight travel
Interaction with the FDA and other regulated bodies during inspections/audits, and in fulfilling requests for information
Working knowledge and application of validation principles and industry practices
Advance knowledge and working application of PFMEA and Risk Analysis

Performance Health is a leader in consumer healthcare and the largest global manufacturer and distributor of products to the rehabilitation and sports medicine markets. The company s products are sold to leading healthcare facilities and practitioners such as physical therapists, athletic trainers, and chiropractors, as well as direct to consumers. Its market-leading brands, which are sold in over 100 countries, include Biofreeze ®, TheraBand ®, TheraPearl ®, Cramer ®, Sammons Preston ®, and Rolyan ®. Performance Health is headquartered in the greater Chicago, Illinois area, with significant operations both in the US and internationally.

Performance Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, and any other characteristic protected by law.

Job Detailstop

Location Cedarburg, WI, 53012, United States
Categories Medical/Health

Location Maptop

Contact Informationtop

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Job Code 303760

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