Senior Quality Engineer
6 days ago
Responsibilities:
- Provide comprehensive quality support for operations and NPI activities, ensuring compliance with ISO or AS9100/IATF 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); analyze 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, caliper's, micrometers, 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.
Requirements:
- Bachelor's degree in engineering required.
- Minimum 8 years of quality engineering experience in medical device manufacturing.
- 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.
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