Job Details
Posted 7 July, 2026
Job Id: 629019
Sr Quality Engineer
Job Description
Pay 50-60/h depending on experience
Top 3 technical skills that are required for the role:
1. Technical Procedure Review and Writing
2. Understanding of NCMR requirements by FDA and ISO
3. The ability to accomplish both daily tasks and longer term tasks at the same time.
Education Required: B.S. in Engineering
Years’ Experience Required: 7-10 years of Medical Device experience
In the role of Sr. Quality Engineer, the person will be asked to perform daily activities that include review and approval of Non Conformances, Document Changes and Validations. Along with daily activities, the person will perform reviews of local QMS Documents, compare them with Enterprise Level Documents, and make the required changes to the Local QMS documents to ensure adherence to the Enterprise Documents. Essential perform QMS Harmonization tasks between local document and Medtronic Enterprise level documents. Engineer may assume responsibility for leading Gemba Walks, documenting risks found during the walks and ensuring the risk get addressed.
Must Have
- 3+ years of experience in the medical device industry, with a strong background in Non -Conforming Materials Reports (NCMR), CAPA, or product quality management.
- Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
- Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry.
- Strong project management skills, with the ability to manage multiple priorities and deadlines.
- Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
- Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
- Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability.
- Experience in Process Validation.
Nice To Have
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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