Associate Director of Quality Assurance
Westford, MA /
At MedAcuity, we work at the intersection of healthcare, technology and innovation in partnership with MedTech companies and innovators to develop custom software for their next-generation software-driven medical devices and solutions. We are looking for an Associate Director of Regulatory Affairs and Quality Assurance who wants to apply their exceptional technical skillset and problem-solving acumen to develop innovative, secure, safe and reliable software to support the product development needs of our MedTech clients.
As the champion for quality principles and compliance, the Associate Director of Regulatory Affairs and Quality Assurance is responsible for product and operational compliance related to medical device design and manufacture, advising employees and clients, and establishing and maintaining quality management systems.
As an influential member of the organization’s security and risk management team, manages the quality assurance function including project audits, ISO certification audits, and audits by clients or prospective clients. Directs the activities of company-wide compliance training within Quality Assurance and brings a passion for governance, risk management, and compliance as a strategic approach, not just a check the box exercise.
- 6+ years’ experience in a similar role with 3 years of hands-on experience leading a QA team
- BS Degree, Computer Science, Information Systems or related technical
- Strong working knowledge of quality procedures, processes, and guidelines
- Pragmatic understanding of computer systems, security, network and systems administration, databases and data storage systems, and telecommunications systems
- Recognized by colleagues as a source of expertise
- Internal and external audit experience
- Experience with quality systems including change controls, CAPAs, deviations
- Effective communication, consulting, customer service and problem-solving skills
- Knowledge of IEC 62304, ISO 14971, ISO 13485 and IEC 60601-1
- A passion and commitment to quality principles and compliance
- Familiarity with regulated software, preferably within the medical device industry
- Demonstrated skills in Regulatory Affairs to advise clients on regulatory matters, and experience working in an FDA regulated environment is attractive
Applicants for employment at Medacuity, LLC are considered without regard to race, color, religion, sex, sexual orientation, gender-related identity/appearance, pregnancy, age, genetic information, national origin, status as a Vietnam Era or disabled veteran or membership in the uniformed services, physical or mental disability, or any other legally-protected classification.
MedAcuity is an equal opportunity employer.