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Synthesis Health
Huntington, WV
Source: Synthesis Health careers · View original posting
From Synthesis Health's posting. “We” and “our” refer to the employer.
Who We Are
We’re a mission and values driven company with tremendous dedication to our customers. Our 100% remote team, spread across the US and Canada, is dedicated to a common goal – to revolutionize healthcare through innovation, collaboration, and commitment to our core values and behaviors.
Synthesis Health is looking for a stellar Senior Post-Market Quality Manager who will be responsible for leading, implementing and continuously improving the post-market quality processes and program for the Company’s Software as a Medical Device (SaMD) products.
The role provides quality leadership across the full post-market life cycle including complaint handling, adverse event assessment, trend analysis, nonconformances, CAPA, field actions, quality monitoring, and recalls. The role also leads the Safety Committee that evaluates and investigates identified safety and potential compliance issues with non-medical device products. The position partners closely with Regulatory Affairs, Chief Medical Officer, Product, Engineering, and Customer Support/Service and other cross-functional teams
to ensure timely identification, investigations, escalation, and resolution of product quality and safety issues.
The ideal candidate brings strong experience with MDSAP quality systems, and post market surveillance of radiology-related SaMD products, combined with an understanding of software development, QA, cloud-based products, unique quality considerations associated with SaMD, and radiology. This role is highly hands-on and requires the ability to independently lead complex investigations and quality initiatives without direct reports.
You can work in a fast-paced environment and juggle multiple projects with overlapping deadlines.
Compensation
Compensation is paid in the currency of the country where the individual is hired. For this position, the salary range is
$100,000 - $120,000 USD.
Other benefits include but not limited to: Medical, Dental, Vision, “Use as needed” vacation policy, and participation in our employee option program.
Synthesis Health is an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law.
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