The Quality Management System (QMS) Specialist will be responsible for providing quality engineering support to ensure delivery of highest quality product to the customer. They will have ownership of the development, implementation, and maintenance of the QMS processes to meet the requirements of applicable quality and regulatory standards (e.g. ISO 13485 and 9001:2015).
Essential Duties and Responsibilities
- Provide active support, expertise, during regulatory audits and inspection, which includes practical experience supporting the cross-functional team. Facilitate and ensure the successful execution of certification and surveillance audits.
- Plan and execute efforts to drive regulatory audit recommendations/observations. Ensure that responses are clear, comprehensive, accurate, and well-written to mitigate potential for further regulatory actions.
- Proactively identify and anticipate risk of non-compliance in a dynamic environment, conformance to regulatory requirements, internal processes and policies. Help track and trend data on common areas of vulnerability.
- Generate and maintain Quality System documentation (SOP's, procedures, forms, work instructions, drawings, etc.) Review for technical accuracy and update as required.
- Assist in the development of risk-based assessments to determine inspection requirements and acceptance criteria by identifying sample size and acceptable error; determine levels of confidence using statistical techniques.
- Guide operations in performing incoming inspection, in-process control, final product testing and release to ensure deliverables of product release are met.
Non-Conformance Reports (NCRs)
- Performs and documents root-cause investigations related to product and components rejections. Formulate corrective and preventive actions; implements those actions in order to improve quality levels and regulatory compliance.
- Work with operations/manufacturing and the contract manufacturer to lead efforts to resolve issues that involve quality system gaps, production non-conformances or situations that involve component qualification or procurement.
- Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects
Verification and Validation
- Provide validation support by applying manufacturing quality tools including, but not limited to: PFMEA, DFMEA, PFMEA, IQ, OQ, PQ, control plans, and process verification/validation plans.
- Prepare reports by collecting, analyzing, and summarizing data. Analyze data and make decisions using valid statistical techniques.
- Participate in supplier qualification and transferring new products from R&D (design transfer) into production following project management strategies including new item setup
Corrective and Preventative Action (CAPA)
- Actively work within the CAPA system, provide inputs to the CAPA Review Board and Monthly Data Analysis.
- Participate in and support Continuous Improvement initiatives
- Participate in external supplier audits and internal audits
- Support regulatory submissions
Job Requirements Critical Competencies
Education and Experience Requirements
- Must have a solid understanding of statistical processes and techniques - use of Minitab is preferred
- Must be detail orientated, well organized, have excellent communication skills, and work well in a team environment
- Must have ability to work on multiple projects simultaneously
- Ability to work effectively in a fast paced and dynamic environment
- Certified Lead Auditor ISO 9000 required
- Bachelor of Science Degree in Engineering or other technical degree, or 8 years' equivalent experience in a Quality role in a regulated manufacturing industry in addition to the minimum required
- At least 5 years' experience in manufacturing environment required; Medical Device Industry experience preferred; Quality or Product Development related roles preferred
- Working knowledge of quality system regulatory requirement ISO 9000 required; Experience in ISO 13485 and/or 21 CFR 820 preferred
- At least 3 years' ownership responsibility of customer or 3 rd party regulatory audit process
- At least 3 years' experience with APQP standards (Process Flow, Control Plan, PFMEA, MSA, and SPC) and QMS standards (ISO 9001)
- Experience with 8D Problem Solving is desired
EEO Statement: The company in which you have expressed employment interest is a subsidiary or affiliate of Altra Industrial Motion Corp. The subsidiary or affiliate is referred to as an ""Altra Company."" Altra Industrial Motion Corp. and all Altra Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. The ""EEO is the Law"" poster is available at:
Individuals who need a reasonable accommodation because of a disability for any part of the employment process will have the opportunity to request accommodation during the application process.
This job has expired.