Senior Quality Engineer (San Diego, CA)

Location: San Diego, CA, United States (on-site)

About the Job

We are seeking an experienced Senior Quality Engineer who will play a pivotal role in Quality Management System (QMS) towards ISO 13485 compliance and provide quality engineering expertise. This is an incredible opportunity for someone who is passionate about being a leader that can work with significant autonomy and independent judgement to achieve our Quality goals and lead continuous improvement projects with cross-functional teams. We are looking for candidates with a solid background in medical devices. Experience with developing strong working relationships with both internal and external customers to influence and enable an effective Quality Culture is a must. This role will report to director of quality assurance and will be a San Diego based role.

If you possess the following and want to make a meaningful impact, we invite you to explore this role.

Responsibilities

• Spearhead development and continuous improvement of QMS processes, including but not limited to calibration and preventive maintenance program, design controls, process / design / software validation, management review etc.
• Interpret regulations and requirements to lead efforts related to Risk Management (FMEA), Verification & Validation, Design History File (DHF), Design Master Records (DMR), Device History Records (DHR).
• Support activities related to audits, NCRs, complaints, change control and new product introductions, including problem resolution, guidance on effective CA/PA, improving documentation
• Provide quality engineering expertise throughout all product lifecycles, from design and development to post-market surveillance, requiring solid understanding of the company’s product portfolio and close collaboration with multiple functions (R&D, Engineering, Mfg, Supply Chain, Commercial, Software etc.)

Required Qualifications

• Bachelors degree in Engineering, Biology, or related science field (an equivalent combination of experience and education may be considered)
• A minimum of 5 years’ experience, preferably in the medical device (Class I-II) or other regulated industry
• Experience with ISO13485 and ISO 14791 is required. Experience with EU MDR, IEC 62304, 21CFR820, 21CFR 211 is strongly preferred
• Experience with wide range of validation including design, process, equipment, product and non-product software is strongly preferred
• Ability to work in a fast-paced and technically challenging environment where adaptability and drive are critical to success
• Strong interpersonal skills with the ability to collaborate closely with suppliers and with internal stakeholders of varying levels to drive Quality System improvements
• Demonstrates an ability to work independently and as part of a team
• Self-motivated and able to organize and prioritize multiple tasks
• Strong inclination and passion for continuous improvement
• Strong analytical skills, reporting, and data analysis are strongly preferred
• Experience working with electronic Quality Management System and manufacturing-related business systems, like ERP and MES, is preferred
• ISO13485 Lead Auditor certification and ASQ CQE certification is a plus

Compensation 

The base salary range for this role is USD 140,000 – USD 160,000 depending on experience, skills, and qualifications. In addition to base pay, this role may be eligible for discretionary bonuses and/or equity grants subject to board approval and company policy. 

Visa Sponsorship 

We are unable to offer visa sponsorship for this position at this time.