Quality Assurance Specialist - Med Device Experience required

Company: GPAC
Location: Hempstead
Posted on: January 8, 2022

Job Description:

Job Description**Experienced Quality Assurance Specialist OpportunityIn Medical Device Industry**Job Requirements/Duties:Help conduct failure investigation reports.Review, process, and trend non-conformances as well as customer complaints.Compile/summarize complaint and/or service information related to Risk Management activities.Provide data analyses in support of internal and external customers as needed, including data related to customer correspondence, surgeon meetings, site visits and regulatory agency correspondence.Support ensuring that quality system activities are in place and are conducted in accordance with applicable regulations and standards including, but not limited to, U.S. FDA Quality System Regulations, ISO (International Organization for Standardization) Standards.Develop standardized reporting mechanisms for departmental, corporate and product Quality Improvement metrics via current ERP/Business Intelligence platforms to support Quality Assurance and Regulatory Affairs users, including query generation, charts, and analysis of Post-Market Surveillance data.Develops and implements solutions to streamline the flow of information and returned material related to Post-Market Surveillance activities.Working cross-functionally, identifies and supports the resolution of issues through the coordination of investigations, identification of adverse trends, and management of complaint and product performance processes.Provide follow-up to internal and external customers as needed.To assure a quality product is in accordance with medical device manufacturing regulations including ISO 13485, IEC 60601 (series), and FDA QSR.Evaluate and audit production operations as part of the Misonix audit team to prevent non-conformance or non-compliance.Review of device history records and review of service records to assure compliance with manufacturing and service specificationsConduct monthly trending performed on product codes and familiesQualified Candidates will have:2 years related experience and/or training; or equivalent combination of education and experience.Experience in the medical device or pharmaceutical industry preferredKnowledge of Good Manufacturing Practices (cGMP) 21 CFR Part 820 Quality System Regulations for medical devices, including ISO13485: 2016 and related standardsstrong organizational skillsstrong Excel capabilities, including experience in standard formula building, Vlookup, charting/graphing, pivot tables.Ability to read and interpret documents such as operating and maintenance instructions, procedure manuals, and drawings.Ability to define problems, collect data, establish facts, and draw valid conclusions.Self-motivation and be capable of working independently with limited supervisionStrong communication skills (written and verbal); Ability to effectively communicate both internally and externally.Important to Know:Must be able to work in the US without sposorshipMust be able to work on-site or in a hybrid modelSeveral locations available, but remote work is not an optionCompetitive Compensation and Benefits***For more information on this opportunity or any others in the Medical Device Industry, contact Millisa Reynolds directly at 605.610.4608**Resumes may be confidentially emailed to millisa.reynolds@gogpac.com Medical Device Companies: If your team needs any position(s) filled, we can also assist in finding qualified talent. Contact Millisa directly605-610-4608 or millisa.reynolds@gogpac.comAll qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 31 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.

Keywords: GPAC, Hempstead , Quality Assurance Specialist - Med Device Experience required, Other , Hempstead, New York