Shire Jobs

Job Title: Advanced Quality Engineer

Job Description

Lead risk management and usability activities for remediation of existing legacy risk and usability documentation to company documentation and forms. Ensure quality assurance documentation to support integration activities and work with cross-functional project teams to support product integration activities. Evaluate overall residual risk for products and present final risk/benefit justification to executive leadership. Identify risks associated with product use (usability). Track the design, documentation, and manufacturing process mitigation activities for all risks. Partner with cross-functional project teams to confirm design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria. Analyze market data (clinical and Post-Market) for risk estimation and address concerns.

Hard Skills

• Formative Studies

• Summative Studies

• Usability

• Medical Device

• IEC

• Risk Management

• uFMEA

• pFMEA

• dFMEA

• Remediation

• DHF

Job Type

This is a contract position with a duration of 12 Month(s).

Work Site

This is a fully remote position. Candidates MUST be willing to work EST Time Zone.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.