Manager of Quality Assurance

SUMMARY:

The Manager 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 U.S. FDA, 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 the Red Star Contract Manufacturing and Response Ortho subsidiaries.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)

• 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 and vigilance, and recalls and 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 help 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

• Develops and facilitates a strategy for a single global quality system and maintains a quality-focused culture

• Manages and ensures compliance to training requirements

• Point of contact and lead for all announced and un-announced QMS and product audits from the FDA or authorized regulatory authorities

• Directs the planning and execution of all internal and external audits

• Develops and maintains the quality department budget

• Reviews and approves document changes for Quality Assurance, as required

QUALIFICATION REQUIEMENTS:

• Bachelor's degree, or equivalent, is required

• 5-7 years of experience in Quality Assurance or Design Quality Engineering

• A minimum of 3 years' experience in medical device

• A minimum of 3 years' experience in a management role with direct reports is required

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

• Experience in design quality engineering, measurement system analysis, and design verification and validation testing is preferred

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

OTHER SKILLS and ABILITIES:

• Strong interpersonal, organizational, problem-solving, and analytical skills with a strong attention to detail

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

• Ability to manage competing priorities and ability to manage projects of various sizes and constitutions

• Management of personnel

• Versatility, flexibility, and willingness to work with changing priorities

• Advanced knowledge of overall business environment, the orthopedic industry and the marketplace, and strong product knowledge

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

• Able to demonstrate the highest ethical standards and 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 and be flexible and proactive towards changing needs plus the ability to handle increasing levels of responsibility

• Must be exceptionally team focused and actively contributes to a positive and innovative work environment with the ability to build and lead a strong QA team and 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 E.U. regulations, including labeling regulations, and regulations outside of the U.S. and E.U., as applicable

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

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