Director of Quality & Compliance

Job description

Tissue Health Plus (THP) is seeking a highly-motivated Director of Quality and Compliance to work in a dynamic, fast-paced start-up environment. A thorough knowledge of medical quality assurance with an emphasis on software is important. Additionally, the successful candidate must demonstrate that they are, first and foremost, a problem solver. The successful candidate must be able to anticipate tasks well in advance of regulatory deadlines and infuse them into the company’s list of priorities.

The Director of Quality will support activities necessary for validating the design and manufacturing process of THP’s flagship products. The Director of Quality will serve as the lead in maintaining compliance with standards for the efficacy and safety of medical electronic equipment and Software as a Medical Device. The Director of Quality will need to interface effectively with vendors, regulatory consultants, the research and development team and the FDA.

RESPONSIBILITIES:

• Act as lead in implementing, maintaining and monitoring THP’s ISO 13485 system, its CAPA system and its audit system.
• Act as lead in maintaining and improving the risk management file at different phases of product development along with any other risk analysis activities necessary for compliance.
• Act as lead in ensuring compliance with ISO 14971, IEC 62304, IEC 60601 and other standards relevant to THP’s flagship devices.
• Act as lead in reviewing, updating and implementing Quality Management System (QMS) and procedures.
• Act as lead in developing internal training sessions around quality and compliance issues.
• Evaluate and approve contract-manufacturers and suppliers.
• Participate in Product Design Verification and Validation activities including composing and executing validation protocols
• Participate in maintaining and improving quality systems for current and future products.

QUALIFICATIONS:

• Must have >5 years of Quality Engineering and Management experience in medical devices, ideally with a focus in imaging. Applicants demonstrating experience with commercialization in a small start-up environment are highly desirable.
• The ideal candidate will have a degree in a relevant engineering field
• Applicant must possess excellent problem-solving, troubleshooting, and communications skills.
• The ideal candidate will have a bachelor’s degree in software, mechanical, electrical or any other relevant engineering field.
• Applicant must be able to work independently, learn quickly, and take on responsibilities outside of this scope of work, as necessary.
• Applicant must be highly motivated, team player.

SUPERVISORY RESPONSIBILITY

This position includes management of quality contractors and supervision of the quality operations of vendors and CMO’s.

WORK ENVIRONMENT

This job operates in a professional office/ laboratory environment, in addition to a manufacturing environment for supplier visits. This role routinely uses standard office equipment such as laptop computers, photocopiers and smartphones, as well as exposure to various test and manufacturing equipment, etc.

POSITION TYPE/EXPECTED HOURS OF WORK

This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.

TRAVEL

Occasional travel may be expected for this position including observation of hardware being used in the field, meetings with business partners and investors, testing of equipment at outside labs, conference and or training events.

EEO STATEMENT

THP is an equal opportunity employer.

OTHER DUTIES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.