Sr. Quality Assurance Specialist (TLE58SF RM 3184)

Position: Sr. Quality Assurance Specialist (TLE58SF RM 3184)

Mandatory experience: SaMD and IE C62304

Duties and responsibilities
As the Sr. Quality Assurance Specialist, this position will:
● Actively engage cross-functionally within the organization, such as with the Engineering, Clinical and Marketing teams, to develop new products within the Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes.
● Act as the Quality lead for design changes to existing DeepHealth products, including non-medical devices, to ensure compliance with the applicable standards and guidances; including the .
● Take ownership of product specific Quality Management System processes, such as CAPAs and complaint management, across the organization to ensure compliance and drive efficiency.
● Work cross-functionally to integrate products as a result of corporate and/or product acquisitions.
● Work as a team member with the Quality Assurance team to ensure compliance to US and OUS standards and regulations.
● Participate in the development of junior staff, as requested
● Collect/monitor quality metrics in support of Management Review

Please Note: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned, and management retains the right to add or change duties at any time.

Qualifications
● Bachelor’s degree in relevant field (or equivalent experience, i.e. Associate’s degree with 5 years of experience).
● Minimum of 5-8 years (8-10 years preferred) working in a regulated industry (FDA and Software as a Medical Device preferred).
● Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
● Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304 preferred.
● Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56, preferred but not required.
● Participation in regulatory audits a plus
● Excellent written and oral communication skills

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