What are the responsibilities and job description for the Senior Quality Engineer position at Talent?
The Senior Quality Engineer will be responsible for the quality, safety, and reliability of my client's Surgical Products.
You will require expertise in supplier, design, manufacturing, and software quality engineering. You must be able to demonstrate an understanding of consumables and sterilization processes.
It is a full time permanent position based in Fremont (3 - 5 days a week in office).
What you'll be doing:
- Quality engineering expertise in supplier management, design control, manufacturing, software quality, and sterilization activities.
- Engineering support
- Work with product development teams
- Participate in Usability Engineering and planning documentation (e.g. EN 62366/ISO 62366,).
- Contribute in software documentation according to IEC62304, biocompatibility testing according to applicable regulations and standards including ISO10993, and EMC testing according to IEC60601-1.
What we are looking for:
- BS or MS in engineering field (mechanical, computer or biomedical preferred)
- 3-5 years of quality engineering experience in medical device industry
- Knowledge of consumables, sterilization processes, and associated regulatory requirements.
- Understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
If you are interested, please apply now or reach out to Jason Pho from Talent on jason.pho@talentinternational.com
Salary : $150,000 - $160,000
