Manager Manufacturing QA

Breathe Life Into Your Career

Respironics, a worldwide leader at anticipating needs and providing valued solutions to the sleep and respiratory markets. The company's focus is on home care, hospital, respiratory drug delivery and international markets providing programs that manage sleep disordered breathing, chronic obstructive pulmonary disease, asthma, infant care, congestive heart failure and restrictive lung disorders. Globally positioned has manufacturing facilities in several domestic and international markets.

We have an immediate opportunity in our Murrysville, PA territory for:

Manager Manufacturing QA

Responsibilities:
Ensure compliance with company quality policy, external standards and all regulatory requirements as they apply to SHR Group quality systems.
Ensure that all corporate and divisional manufacturing quality objectives are achieved.
Support development and execution of process validation processes cooperatively with Manufacturing Process Engineering.
Provide expertise in developing process risk management processes and post-market risk management activities.
Provide oversight and support to material review and nonconforming materials disposition.
Coordinate supplier and material improvement initiatives with Supplier QA and Purchasing.
Manage process audits, document audits, and final release reviews to provide thorough independent oversight to Manufacturing, Product Testing and Quality Control functions.
Lead and/or provide support to process control improvement initiatives, including implementation of Six Sigma and APQP projects / programs in the manufacturing environment as required.
Work in conjunction with NPD QA to coordinate quality activities associated with new product and revised product introductions and pilot builds.
Provide quality training to Manufacturing associates.
Partner with Manufacturing to develop and facilitate quality awareness and prevention processes.

Requirements:
BS degree in Engineering or related field. Unique combinations of education and experience may substitute if they provide essential skill sets for the position.
Minimum of 6 years quality department management experience in medical device or related industry. Experience with Codes of Federal of Regulations (21 CFR, Part 801, 803, 806). Professional quality certification (CQE,CQA, CQM, CRE) and experience with SAP preferred.
Partner well with internal groups to achieve business goals
Demonstrate good judgment and decision making to ensure that Quality Assurance interests are well represented in supporting the organization.
Exhibit good problem solving abilities to work through technical problems.
Action oriented to develop and implement solutions to opportunities as they surface.
Growth: The successful candidate will:
Take accountability to execute personal development plan to grow within current role
Continually improve Respironics? quality management system through the pursuit of ongoing education to broaden knowledge base. Develop an expert understanding of regulations and guidelines governing medical device development including QSRs, ISO 9000, ISO 13485, ISO/IEC 17025, CMDR, and the MDD.

At Respironics Inc., our products improve the lives of patients with a variety of respiratory needs in the hospital, homecare, critical care and neonatal environments. To learn more about our organization, our products and our culture ? please apply online and reference job number: 348BR.

Your interest in our company is appreciated however, only candidates considered for interview selection will be notified. AA/EOE.

www.respironics.com
Apply Online: https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=25012&siteid=5146&AReq=348BR&Codes=MON