Senior Supplier Quality Engineer - Element Science

SENIOR SUPPLIER QUALITY ENGINEER

THE COMPANY:

Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home. By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort, and ease-of-use, aim to redefine the paradigm of care for these patients.  Our first product, a wearable patch defibrillator, is initially targeted at treating the more than 500,000 patients in the US with an elevated temporary risk of potentially experiencing a lethal heart rhythm.  Based in San Francisco and Redwood City, California, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE:

Element Science is building a world class medical device design and manufacturing team. We are looking for a Sr. Supplier Quality Engineer with a passion for working on devices that save lives. This individual will support the product development and operations team in identifying, qualifying and developing suppliers in accordance with ISO 13485 requirements. This individual will be responsible for providing quality support and oversight to ensure that the products are developed in compliance with company SOPs and other regulatory requirements. The candidate shall have excellent people skills and a can-do attitude to deliver solution.

RESPONSIBILITIES:

• Manage control of external suppliers and contract manufacturers to ensure supply of quality materials.
• Act as the quality representative in external supplier communications.
• Lead supplier qualification program and maintain an up-to-date Approved Supplier List.
• Generate supplier related metrics and execute data driven improvements.
• Communicate supplier related issues to responsible supplier representative and facilitate the resolution of supplier issues through quality process e.g., SCAR.
• Support improvement of supplier processes through audits and feedback to suppliers.
• Collaborate with suppliers on creation and maintenance of quality tools such as FMEAs, control plans.
• Support improvement of Standard Operating Procedures and/or Work Instruction as part of the Quality System procedure.

QUALIFICATIONS:

• 7+ years of relevant experience in Medical Device environment.
• Working knowledge of current ISO 13485 standard, QSR, and ISO 14971.
• Bachelor's Degree in Science or Engineering, Master's degree is a plus.
• Ability to work in a team environment, manage multi-tasking, and disciplined in completing tasks on schedule.
• Excellent written and verbal communication skills.

BENEFITS: 

Element Science offers a very competitive salary and benefits package including, but not limited to:

• Stock Options
• 90% employer-paid medical, dental, and vision insurance
• Company-paid Basic Life Insurance
• 401(k) retirement plan (Traditional and Roth)
• Competitive Paid Time Off
• Paid Holidays
• FSA (Flexible Spending Accounts)
• HSA (Health Savings Account)
• Employee Assistance Program through PEO

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

• Salary Range: $125,000 - $150,000 + Annual Bonus