6Q02 - Quality - QAEN - QUALITY ASSURANCE ENGINEER

6Q02 - Quality - QAEN - QUALITY ASSURANCE ENGINEER

Job Description

Posted Monday, July 7, 2025 at 5 : 00 AM | Expires Monday, September 8, 2025 at 4 : 59 AM

TITLE : Quality Assurance Engineer

POSITION OBJECTIVE : Assists the Quality Assurance and Regulatory Affairs Manager in regulatory compliant company-wide quality assurance department that provides all research, support, product development, and quality assurance functions required along with accurate specifications, service, and delivery of product to our customers. Assist the Quality Assurance and Regulatory Affairs Manager in the management of the quality assurance department to support production schedules, personnel, resources and continuous improvement efforts that achieve efficient service productivity. Assists the Quality Assurance and Regulatory Affairs Manager in the evaluation and controls to vendor reliability of goods and services.

QUALIFICATIONS :

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Bachelor's degree in industrial engineering, mechanical engineering, or business from an accredited four-year college is preferred. Associate's degree or equivalent from an accredited two-year college / technical school, or higher will be considered, plus 2-4 years of quality assurance engineering experience in a medical device manufacturing environment; or equivalent combination of education and experience. Experience in Plastic Injection and / or Blow Molding is desired.
• Must have working knowledge of the FDA 21 CFR Part 820 Quality System Regulation.
• Working knowledge of ISO 13485 : 2016 Standard is preferred.
• Current certified ISO 13485 : 2016 Lead Auditor certificate is preferred.
• Computer literate in Microsoft Office suite and experience with imputing data into database systems is a must. Proficiency in SAP is a plus.
• Ability to apply common sense understanding to carry out detailed written or oral instructions. Ability to deal with problems involving concrete variables in standardized situations.
• Ensure consistent, dependable attendance and demonstrate a willingness to accommodate non-standard work hours as necessary.
• Capable of effectively managing job-related stress and fostering productive workplace interactions.

JOB RESPONSIBILITIES :

WORK ENVIRONMENT CONDITIONS SUBJECTED TO IN THIS POSITION :

Inteplast Group is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at applicantaccommodation@inteplast.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information, about our commitment to equal employment opportunity, view the EEO - Know Your Rights and Pay Transparency Statement .

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