Quality Engineer
Quality Engineer
Posted on :
12-09-2025
Employer Active
1 Vacancy
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Job Description
Responsibilities:
- Provide comprehensive quality support for operations and NPI activities ensuring compliance with ISO 13485 (or AS9100/IATF 16949) and FDA CFR820 standards.
- Lead and document root cause analyses CAPA and nonconformance investigations for customer complaints supplier issues and nonconforming materials.
- Support and document validation efforts (IQ/OQ/PQ) for processes equipment and products; maintain validation documentation.
- Perform capability studies (Cpk) FMEA and advanced metrology practices (GD&T); analyse and organize data using Minitab Excel and related tools.
- Resolve customer complaints and product issues maintaining professional communication and data-driven solutions.
- Collaborate with inspectors and technicians on product inspection and testing using vision systems CMMs callipers micrometres and more.
- Interface with suppliers and internal teams to drive process improvements maintain documentation control and foster a continuous improvement culture.
- Ensure all quality activities align with regulatory customer and internal requirements; participate in internal and external audits.
- Bachelors degree in engineering required.
- Minimum 8 years of quality engineering experience in medical device manufacturing (aerospace or automotive experience also considered).
- Expertise in ISO 13485 FDA CFR820 AS9100 or IATF 16949 standards.
- Proven experience leading CAPA Client activities and validations in manufacturing settings.
- Experience collaborating with customers to resolve complaints and product issues.
- Advanced knowledge of metrology GD&T and interpreting CAD/blueprints.
- Hands-on experience with industrial machinery such as CNC EDM and finishing equipment preferred.
- Proficient in Minitab Excel and technical documentation software.
- Strong leadership communication and process ownership skills.
Employment Type
Full-time
Key Skills
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