Design Control Quality Engineer

Description:

• Act as a quality engineer for medical device QMS quality improvement activities, with a focus on design controls and risk management.

• Provide oversight of quality improvement activities and ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and other applicable domestic/international regulatory requirements, including Gilead quality system requirements.

• Plan and support implementation of approved quality improvement action items and deliverables.

• Interface with internal stakeholders and contract manufacturers to address and resolve complex technical drug-device combination product, process, and quality issues.

• Act as an escalation contact for complex and high impact quality issues, concerns and decisions.

• Support strategic relationships with internal cross-functional teams and related CMOs.

• Provide training as needed for cross-functional stakeholders.

• Provide guidance and impact assessments for Change Control, including DHF/RMF assessments.

• Write and/or implement changes to controlled documents (e.g., SOPs, specifications, test methods, etc.).

• Anticipates shifts in industry trends and regulatory environment that will impact Gilead's business needs and positions the function to respond accordingly.

• Collaborate with R&D during new combination product development and provide input into the design controls process.

Skills:

Risk management, quality management system, iso 13485, medical device, design control

Qualifications:

• Demonstrates understanding and application of QSR/GMP principles, concepts, best practices and standards in the US and internationally.

• Can develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.

• Demonstrates strong knowledge of medical devices, combination products and general pharmaceutical manufacturing.

• Can provide guidance to solving problems, uses Gilead Quality standards, regulations and industry best practices.

• Demonstrates knowledge of industry best practices and trends.

• Demonstrates excellent verbal, written, and interpersonal communication skills.

Typical Education & Experience:

• 3+ years of relevant experience in a GMP environment related field and a BS or BA. OR 4+ years of relevant experience and a MS.

• Knowledge and experience in quality assurance for development of drug-device combination products

• Previous experience with combination products is required, such as autoinjectors, co-packed kits, pre-filled syringes.

• QA experience in both clinical and commercial combination products.

• Strong project management and process improvement skills.

• Demonstrates understanding of domestic and internal quality systems regulations to adopt best in class systems/processes and drive continuous improve

• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics is preferred.

• Knowledge of Risk Management principles according to ISO 14971, including the use of risk management tools such as FMEA.

Experience Level:

Intermediate Level

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 for other accommodation options.