Design Control Quality Engineer

$70 - $75/Yr

Actalent - Foster City, CA

- Mid Level

Hybrid - Foster City, CA

Administrative and Support Services

About the position

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.

Responsibilities

• Act as a quality engineer for medical device QMS quality improvement activities.
• 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.
• 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.

Requirements

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

Nice-to-haves

• 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.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)