Software Quality Compliance Manager

DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. We are in search of a passionate Software Quality Compliance Manager to develop and lead a talented software quality team in a research and development environment. The ideal candidate will be a technically astute, detail oriented individual who is experienced with delivering safety critical software to the FDA. This includes the delivery of all the regulatory documentation, and knowledge of techniques and practices to achieve product acceptance by the FDA.

How will you make a difference?

• Lead DEKA’s software quality initiative in a product development environment.
• Ensure DEKA’s quality management system process and regulatory strategy is actively followed.
• Ensure compliance is considered during the creation of software documentation; including plans and reports for user requirements, software design and development, verification and validation, risk analysis, and traceability between elements.
• Participate in design reviews, hazard and risk analysis, test protocols, and product requirements, as required, for medical device software, software as a medical device and automated processes.
• Work with Regulatory to develop documentation for submissions (510k, PMA).
• Actively contribute to SOP’s; creating, updating, maintaining, and harmonizing to standards, regulations, and FDA guidance documents.
• Manage, mentor, and develop the software quality compliance and assurance teams.

What are we looking for?

• BA/BS in Computer Science, Computer Engineering, Biomedical, or related technical field.
• 7 plus years working in a regulated industry. FDA and medical devices preferred.
• Detailed knowledge and experience implementing IEC 62304-software compliance.
• Detailed knowledge and experience implementing FDA software guidance.
• Excellent organizational, interpersonal and verbal and written communication skills.
• Strong problem-solving ability and exceptional attention to detail.
• Ability to effectively manage multiple simultaneous tasks and priorities.
• Strong teamwork mindset, desire to learn and share information with others.
• Ability to maintain confidentiality and discretion and exercise good judgment.
• Experience with IDE, 510K and PMA submissions desired.
• Prior experience with a programming language (e.g. C++, Python, Java), desired.

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