Manager of Quality Systems and Operations

 

Title: Manager of Quality Systems and Operations

Location: Philadelphia area, PA



Our client is seeking a Manager of Quality Systems and Operations. The client is a leading developer of medical devices in Europe as well as the Far East. They have established a corporate presence here in the U.S. and are developing the Executive staff. This position will be responsible for developing the quality systems for an operation that is currently importing devices, re-packaging devices and ultimately developing devices stateside as well.

Quality Systems & Operations Manager responsibilities would include:

Integrate, build into company and monitor the Company’s current quality system based out of Italy, including the Quality Manual and Quality System Procedures, to ensure consistency and conformity to established quality standards with the FDA. Perform trend analyses and initiate and/or follow-up on required actions. Schedule and oversee annual Internal Quality Audits for the Company. Maintain current quality standards including environmental controls.Oversee complaint tracking, reporting and device traceability.Understand Design controls and interface with R&D in Europe on a daily basis.Put together technical reports on information gathered from Manufacturing.Repackaging and relabeling for US distribution on products imported from Europe.Serve as the Management Representative for the Company’s Quality System. Work with all departments and business partners as required to resolve quality issues in a timely manner. Report on the quality system to top management on a regular basis.



Requirements

Bachelors degree. 5-10 years work experience in a medical device environment. 5 years experience in QA and QC. Experience in developing and managing quality systems in accordance with ISO, FDA and EU quality standards. Experience in managing complaints, trend analysis, internal audits, document control, and product testing. Strong management, communication and interpersonal skills. Ability to write and review procedures and reports.



MUST HAVE MEDICAL DEVICE EXPERIENCE

Please send resume in WORD format to Michelle@MullingsGroup.com