Medical Device QA

Position: Medical Device QA

Location: Waukegan IL (Hybrid 3 Days Onsite a week)

Duration: 1 Year (12 Months Contract)

Note: Candidates with QA experience on Medical Devices.

Description:

Primarily responsible for representing QA on cross-functional Software as a medical device (SaMD) and Digital Health Software product development teams and executing Quality System requirements to ensure products are developed, tested, and released in compliance with worldwide Medical Device Regulations.

Responsible for authoring, reviewing, and approving project documentation associated with the SDLC and design control requirements to support Corporate, Division, FDA, and other regulatory requirements.

In addition to these primary areas of focus, quality assurance will also be responsible for creating and maintaining QMS documents for the development of SaMD’s and Digital Health Software Products in compliance with global regulations.

Qualifications

• Bachelor’s degree or equivalent is required; preferably in sciences, engineering or other technical/scientific areas.

• 5+ years of industry (or 3+ years and Master) experience in Quality Assurance, Development or healthcare related field. Experience in Medical devices, specifically development of Software Medical Devices is desired.

• Strong understanding of regulations and standards affecting software medical devices such as IEC 62304, 21 CFR 820.30 and EU MDR.

• Experience with creation and maintenance of QMS documents for development of medical devices.

• Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills.

• Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management.

• Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues.

• Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities.

• Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required.

• Capable of clearly presenting and justifying quality requirements to management.

Responsibilities

• Perform QA activities related to Software as a Medical Device (SaMD) and Digital Health Software Product Development

• Ensure compliance with Client software lifecycle policies and procedures.

• Perform design control and risk management activities according to Client Quality System

• Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met.

• Support the creation of regulatory submission documentation.

• Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.

• Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.

• Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements.

• Write/review policies/processes/procedures and related documents for the development of SaMD’s and Digital Health products in compliance with global regulations.

• Apply knowledge of global regulations, guidance's, and Corporate and Function standards.

• Lead/assist in the preparation of and support regulatory agency and internal audits.