Director of Quality Assurance

SUMMARY:

Director of Quality Assurance is responsible for managing all facets of quality assurance, including ownership of the Quality Management System for Wishbone Medical. The primary focus is to ensure that the Quality Management System (QMS) and all aspects of Quality Assurance are compliant to current and future USFDA, ISO and MDR Standards and Regulation for Medical Devices (including Sterile Packaging) for WishBone products. As WishBone Medical is a virtual manufacturer, this position also provides guidance for quality activities at RedStar Contract Manufacturing and Response Ortho subsidiaries.

PRINCIPAL DUTIES AND RESPONSIBILITIES

- Ensures the QMS and Design Quality requirements are effectively established and maintained in accordance with medical device regulations and international standards.

- Responsible for business processes that ensure conformance of the device with the QMS prior to release and for post-market surveillance.

- Responsible for management of the Design Quality Engineers, as well as oversight and prioritization of departmental tasks and projects.

- Develops systems, implements and trains employees on quality and regulatory requirements including, but not limited to, corrective and preventative actions (CAPA), quality audits, post market surveillance/vigilance, and recalls/removals.

- Manages systems for design, development, verification, validation, distribution, storage, tracking, post market surveillance and retrieval of information pertinent to the design quality processes.

- Supports product development teams to meet their objectives

- Oversees Quality Metrics and Quality Initiatives, including responsibility for quarterly and annual internal reporting.

- Leads and manages post-market surveillance, including device investigations for complaints and field actions.

- Develop and facilitate a strategy for a single global quality system and maintain a Quality-focused culture.

- Manages and ensures compliance to training requirements.

- Point of contact and lead for all announced and un-announced QMS/Product audits from the FDA or authorized regulatory authorities. Directs the planning and execution of all internal and external audits.

- Develop and maintain quality department budget.

- Review and approve document change for Quality Assurance as required.

- Miscellaneous responsibilities as assigned

EXPECTED AREAS OF COMPETENCE

- Strong interpersonal, organizational, problem-solving and analytical skills; strong attention to detail.

- Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, peers, and direct reports.

- Ability to manage competing priorities; ability to manage projects of various sizes, constitutions, and management of personnel; versatility, flexibility, and willingness to work with changing priorities.

- Advanced knowledge of overall business environment, the orthopedic industry and the marketplace; strong product knowledge.

- Must work precisely according to procedures, rules and regulations, has a passion for continuous improvement and quality.

- Able to demonstrate the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

- Ability to function well as a member of the team and team leader, as well as build relationships between QA and other areas of the organization.

- Must have service-oriented approach, flexible and proactive towards changing needs; ability to handle increasing levels of responsibility.

- Must be exceptionally team focused and actively contributes to a positive and innovative work environment; ability to build and lead a strong QA team; ability to lead and influence others.

- Ability to identify and assess business risks to develop Quality strategy.

- High level of proficiency in Microsoft Word, Outlook, Excel and PowerPoint is essential.

- Ability to negotiate with regulatory agencies, management, and other groups as necessary.

- Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU as applicable.

Experience Requirements

- Bachelor's Degree or equivalent is required

- 7-10 years of experience in Quality Assurance / Design Quality Engineering

- A minimum of 3 years of experience in medical device.

- A minimum of 3 years in a management role with direct reports is required.

- A combination of education, experience, leadership, strategy and QA/RA influence may be considered.

- Desired experience in design quality engineering, measurement system analysis, and design verification/validation testing.

- Working knowledge of Design Controls Process and Quality System Regulations for Medical Devices.

Current Openings for Director of Quality Assurance Jobs at XXX DO NOT USE XXX WishBone Medical, Inc

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