Regulatory and Quality Assurance Specialist II

5 hours ago

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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US Fertility

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B2B • Science

US Fertility is the largest physician-led fertility network in the United States, bringing together reproductive medicine practices to deliver high clinical standards and improved pregnancy rates. The organization provides practice management and laboratory management services to fertility practices, operates a Research Division, runs an Innovation Fund to invest in early-stage fertility-related ventures, and supports academic programs and physician training. US Fertility partners with physician-owned clinics across many locations to scale operations, improve patient outcomes, and expand access to reproductive care.

1001 - 5000 employees

🤝 B2B

🔬 Science

📋 Description

• Implement, monitor, maintain, and improve the company’s Quality System • Implement, monitor, and maintain a document control system • Interpret and assure conformance to federal and state regulations that are applicable to the products produced/processed • Assure appropriate licensure is held and maintained by the company • Facilitate quarterly meetings with medical directors to provide regulatory and quality updates • Ensure medical directors complete all signoffs as required • Assure compliance to international regulatory agencies • Tracking and trending of laboratory, cryogenic, andrology, and deviation systems • Maintain and improve deviation/non-conformance system • Report events to regulatory bodies as applicable • Assure training and competency of all staff • Assist in preparation of regulatory strategies for changes to existing systems • Participate in Continuing Education programs in related field • Participate in planning and implementation of regulatory systems, document/change control and validation activities • Establish and maintain good working relationships with department heads, regulatory authorities, and government agencies • Implement and oversee audits for departments and systems to assure compliance to regulations and standards • Track and ensure any identified deficiencies are rectified post an inspection/audit event • Monthly and quarterly in person audits of quality and regulatory manuals and records • Monthly and quarterly reports to leadership on Quality and Regulatory activities • Perform other related duties as assigned by management

🎯 Requirements

• Bachelor’s degree or equivalent combination of training and experience • Must have a high level of interpersonal skills to handle sensitive and confidential situations. • Position continually requires demonstrated poise, tact, and diplomacy • Must be able to interact and communicate professionally with individuals at all levels of the organization • Clear and effective communication skills • Proficiency in a variety of computer software applications in word processing, spreadsheets, database, and presentation software (MSWord, Excel, PowerPoint) • Self-starter that adapts well to change in a fast-paced, dynamic environment • Prior laboratory experience preferred • Knowledge of industry, Federal and State regulations, licensing processes • Strong aptitude for analyzing data, audit processes and reconciling records • Demonstrated organizational skills and the ability to prioritize and coordinate multiple processes • Excellent interpersonal skills and ability to work as part of a multi-disciplinary team and build and maintain effective working relationships. • Excellent verbal & written communication skills • Ability to work as part of a multi-disciplinary team • Ability to organize and lead collaborative teams to facilitate quality projects (validations, corrective action plans, etc.) • Occasional travel required (up to 25%) • Able to adapt and thrive in the fast-paced, rapidly changing environment

🏖️ Benefits

• Competitive pay + bonus • Comprehensive training • Medical, dental, vision, and 401(k) matching • Generous paid time off and holidays • Retirement plan • Tuition assistance • Ability to make an impact in the communities we serve