Polyzen is a leading developer and manufacturer of customized polymer-based materials, films, components, and assemblies for the medical device industry.
The Quality Assurance Engineer develops, coordinates, and implements various activities pertaining to the effective management of the Quality Management System (QMS) in accordance with 21 CFR Parts 810, 811, 820, ISO 13485:2016, customer requirements, and applicable standards. The ideal candidate for this role will be detail-oriented, with the ability to work on and coordinate multiple projects. The position is based on-site in Apex, NC.
What you will do:
- Performs and documents Nonconformances, Deviations, Returned Material Authorizations (RMAs), and Supplier Corrective Action Requests (SCARs) as applicable.
- Acts as lead on assigned CAPA requests to investigate, develop, drive and document required actions and closure within prescribed timelines.
- Assists with completion of equipment qualification, process validation protocols and reports; may also assist with Receiving, First Article and In-process inspections.
- Integrates customer label designs into software program and approves printed labels for manufacturing.
- Supports customer complaint investigations, performs root cause analysis, and develops corrective and preventive actions as requested. Works with customers to provide required technical support and information regarding the investigation.
- Authors documents: Test Method Validation Protocols and Reports, Inspections (Incoming, in process, Final), Specifications, Procedures, Work Instructions, as required.
- Participates in customer meetings and assists Program Management in the transition of new Customer designed products into production when requested.
- Reviews/approves records pertaining to the controlled production environment (cleanroom logs, monitoring reports).
- Performs statistical data analysis utilizing statistical software (Minitab and Excel).
- Compiles data requested for Management Review and supports FDA Inspections, Customer and Third-party Audits as required.
- Reviews calibration certificates as needed, may perform internal or supplier audits.
- Assists in training of new or existing personnel.
- Adheres to GMP/QSR requirements and follows applicable QMS to successfully accomplish job requirements.
- Follow Personal Protective Equipment (PPE) policies and gowning procedures in designated areas.
- Follows established safety requirements and adheres to the Health Safety and Environment Management System.
- Performs other job-related responsibilities as assigned.
*
Who you are:*
- Bachelor’s Degree related to life sciences
- Possess 5 years of Quality Control or Product Development experience in a regulated environment, such as ISO 13485:2016, 21 CFR Parts 810, 811 and 820
- Validation experience and demonstrated use of Quality tools/methodologies
- Detailed knowledge of ISO 13485:2016 and FDA Regulations 21 CFR Parts 210, 211 and 820
- Demonstrated ability to organize and manage small to medium-sized projects
- Certified Auditor (ISO 13485: 2016), highly desired.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Type: Full-time