Process Quality Engineer
200 Minuteman Road Suite 302 Boston, MA 01810
Our client. is currently looking for a highly motivated Process Quality Engineer to join our team and help revolutionize transplant medicine. Based at our headquarters, this is a hands-on role in a fast-paced and dynamic medical device company.
- Support day-to-day manufacturing activities.
- Lead efforts to identify and resolve manufacturing non-conformances (containment, root cause investigation, corrective action).
- Support process validation activities.
- Support new product development programs.
- Support/lead investigations of complaints due to manufacturing defects.
- Support internal audit and manufacturing GMP/ISO 13485 audit programs.
- Lead/assist with manufacturing Corrective and Preventive Actions (CAPA).
- Identify product and process improvements; lead or support their implementation.
- Create production documentation including manufacturing, inspection and test instructions.
- Support training program for production team and quality inspectors.
- Perform other tasks and duties as required.
- BS in Engineering or related discipline with 5-10 years of experience as a Quality/Manufacturing Engineer in the medical device manufacturing industry including 2+ years supporting manufacturing of consumable/disposable products.
- Thorough knowledge and understanding of FDA QSR and ISO 13485 regulations.
- Experience in medical device manufacturing and EtO sterilization of disposable medical devices.
- Experience leading or supporting process validation activities.
- Thorough understanding of basic statistics and experience using Minitab (or similar statistical software packages).
- Ability to define problems, collect and analyze data, and draw valid conclusions.
- Ability to communicate ideas and information clearly, effectively and concisely.
- Highly detailed oriented with strong organization and prioritization skills.
- Must possess a high level of energy with the ability to handle multiple projects and changing priorities.
- Must be results-driven and exhibit a sense of urgency.
- Lean Six Sigma training/certification is a plus.
Arshad is a seasoned recruiter in the healthcare space with over 15 years of experience in promoting career growth for healthcare professionals. He has played a critical role in the launch of several startup companies. He is known for versatility and leadership; expert in overseeing high-level priorities and a broad range of responsibilities.