MedRhythms is looking for a Quality Assurance Specialist to ensure that our revolutionary medical technology is up to the highest standards of safety, security, and quality. Join our dynamic team where we are committed to and value people as well as your potential. 

We are seeking an individual with a passion for our mission, and is eager to grow and thrive in a collaborative environment. Ideally we are looking for a candidate who has a background in or experience working with software products within an FDA-regulated environment. A love of teamwork, collaboration and strong communication skills are core requirements. We are seeking someone who is thorough, thoughtful, and organized, with comfort working across all areas of the quality management system and medical device lifecycle. Experience in post-market surveillance, continuous improvement, as well as providing training and support is a plus. Most importantly, this candidate should be genuinely committed to the MedRhythms mission to thoughtfully pose insightful questions that ensure we provide our customers with the best services possible. Whether you are an Associate looking to kick-start your career or a seasoned Senior professional seeking new challenges, we welcome you to apply.

Compensation will be in alignment with market data, commensurate with experience, skills and qualifications, and a combination of salary and bonus potential. The Total Compensation package for full time employees includes multiple factors; base pay, annual performance bonus, stock options, health insurance, paid time off and various other benefits. This position will be hybrid with some work out of the MedRhythms headquarters in Portland, Maine; however candidates based outside of Maine will be considered. 

Responsibilities

• Provide quality input into and at times may lead/coordinate design changes, nonconformances, corrective and preventive actions (CAPA’s), and, if necessary, field actions. Participate in the risk management process as needed. 
• Facilitate the complaint handling process, including evaluating all assigned reported product experiences for potential complaints within the defined timeframes. Additionally, will evaluate product feedback, complaints, and adverse event reports for trends or issues requiring further investigation.
• In collaboration with the Product team, monitor and analyze post-market data related to device performance and safety. 
• Maintain quality system software, ensuring appropriate user access, training, and effective integration with other business applications.
• Facilitate appropriate quality system maintenance, including updating procedures to reflect any changes in processes or regulations, as well as ensure proper storage of documentation and record-keeping for traceability and quality control purposes.
• In collaboration with the Head of Regulatory and Quality, participate in site audit/inspection readiness, preparation, participation, and response activities. Coordinate audit/inspection findings and opportunities for improvement. 
• Provide supplier quality assurance support, including evaluation of risk level, identifying approval needs, performing supplier audits and executing quality agreements, as needed.
• Review design and development activities for design changes and new product development to ensure that the project remains in compliance at all times with applicable standard operating procedures, relevant guidelines, regulations and standards. As needed, review verification and validation protocols and reports for adherence to SOPs and relevant standards/regulations/requirements, and may participate in design reviews and confirm that all documentation relevant to the review is included within the Design History File (DHF).
• In collaboration with the Operations team, establish and refine required inspection and test procedures to ensure that the product will continue to meet outlined specifications.
• Identify opportunities to proactively assure compliance to all applicable quality standards and regulations.

We’re looking for you to bring

• Knowledge of 21 CFR 820 and/or ISO 13485 pertaining to quality systems and practical experience implementing. 
• Persistence to ensure that all operations are pragmatic and effectively meeting quality standards.
• Excellent oral, written and presentation communication skills. In addition, must have strong interpersonal skills, including comfort communicating across all departments and with a remote and distributed team.
• Embrace both interpersonal and operational flexibility and versatility. 
• Demonstrated project management and organizational skills with the ability to track and report progress against established milestones, metrics and deliverables.
• Ability to work independently in a dynamic, growing entrepreneurial environment.

Helpful experiences and skills (if you don’t have them, it’s not a dealbreaker)

• Knowledge of digital health technologies and/or digital therapeutics.
• Knowledge of medical device reimbursement, health care compliance, HIPAA and information security.
• Knowledge of compliance in advertising and promotion of medical devices.

What we can offer you

• Meaningful, purpose driven work on a life-changing product
• Collaborative, supportive, smart and fun team
• Competitive compensation and benefits: Medical, dental, vision, life & disability, stock options, bonus potential, paid parental leave
• Generous paid time off: Unlimited vacation, sick and volunteer time off
• Flexible hybrid work environment: Work where and when you are most productive
• Downtown Portland, Maine office: Inviting office in the heart of the Old Port

At MedRhythms, we value the passion and diversity that people bring with them everyday. It is crucial to our culture when it comes to building a successful and innovative team. If you are unsure whether your experience is a perfect fit for the position you are interested in, we encourage you to apply.

We are an equal opportunity employer and welcome people of diverse backgrounds, experiences, abilities, and perspectives. If you require reasonable accommodation in completing this application, interviewing, or otherwise participating in the talent selection process, please reach out to [email protected]