Sr Quality Engineer

• Act as the Quality Engineering representative on multi-functional teams
• Employ quality principles and company’s procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering
• Ensure development and lifecycle management of final product align with dynamic global regulations and standards
• Provide Quality technical expertise, Quality oversight, and serve as a single point of Quality contact for combination and non-combination products associated with final product activities
• Ensure program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans
• Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers related to life cycle management of commercial programs
• Train and educate key functional partners and management on combination product requirements, standards and regulations
• Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of final product programs
• Plan and lead continuous improvements to the quality processes related to devices, combination product, assembly, labeling and packaging
• Provide independent design review for other programs
• Provides quality oversight of the development, qualification, validation, transfer and maintenance of physical test methods including sample selection
• NOTE: This role may require working in shifts or extended hours within the same shift

• Doctorate degree
• Master’s degree and 4 to 6 years of Quality experience
• Bachelor’s degree and 6 to 8 years of Quality experience
• Diploma and 10 to 12 years of Quality experience
• 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)
• Bachelor’s Degree in a Science Field
• Ability to oversee multiple medium complexity projects simultaneously
• Working knowledge of quality engineering and/or mechanical engineering
• Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211)
• Prior experience working as part of a combination product launch team
• Able to successfully manage workload to meet timelines
• Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Experience driving decision making by using Decision, Advice and Inform (DAI) principles
• Understanding of industry requirements/expectations of a Quality Management System (QMS)
• Understanding of the applicable manufacturing/testing processes (i.e. Active Pharmaceutical Ingredient, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Execution of technical standards, internal requirements, and regulations
• Comfortable with both drug and device terminology
• Ability to travel +/- 15-20% of time to domestic and international Amgen sites

• 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)
• Prior experience working as part of a combination product launch team
• Experience driving decision making by using Decision, Advice and Inform (DAI) principles

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards