What are the responsibilities and job description for the Quality Engineer position at TEKhops?
Job Title: Quality Engineer
Location: Pittsburgh, PA
Job Description:
We are seeking a Quality Engineer to lead and support design control activities, ensuring compliance with FDA and international regulations. This role will involve coordinating design review meetings, participating in Design Failure Modes and Effects Analysis (DFMEA), and overseeing verification and validation (V&V) planning.
Key Responsibilities:
Support the development and review of process and equipment validation/qualification (IQ/OQ/PQ) and MSA of internal processes.
Work with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems.
Interface with Manufacturing Engineers to review processes for new products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
Assist with complaint investigation and documentation interfaces with Regulatory Affairs to support UL, IEC, and FDA submissions. Participates in internal audits conducted by internal employees and regulatory agencies.
Develop and execute supplier qualification processes, including supplier contracts and PPAPs.
Manage and drive timely resolution of nonconformances (NCs) and corrective & preventive actions.
Required Skills:
Bachelor’s degree in Engineering, Quality, or a related field.
8 years of experience in medical device quality engineering or a related field.
Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).
Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
Nice to Have:
Proficiency in statistical analysis tools (Minitab, JMP, Excel) and problem-solving methodologies (8D, DMAIC).
Certified Quality Engineer (CQE) or Six Sigma certification.
If you have the relevant experience please forward the resume at Rishi@tekhops.com