Sr Quality Engineer

Career CategoryQualityJob DescriptionLet’s do this. Let’s change the world. In this vital role you will 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, to ensure development and lifecycle management of final product align with dynamic global regulations and standards.The Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercialization. In addition, this role will also support various aspects of the product lifecycle including complaint investigations, expansion and transfer of products to new manufacturing sites, inspection readiness activities, and platform support and improvements.Responsibilities: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 regulationsContribute 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 programsScope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, electromechanical on-body injector systems, and accessories.Plan and lead continuous improvements to the quality processes related to devices, combination product, assembly, labeling and packaging.Provide independent design review for other programsProvides quality oversight of the development, qualification, validation, transfer and maintenance of physical test methods including sample selectionNOTE: This role may require working in shifts or extended hours within the same shiftWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications.Basic Qualifications:Doctorate degree ORMaster’s degree and 4 to 6 years of Quality experience ORBachelor’s degree and 6 to 8 years of Quality experience ORDiploma and 10 to 12 years of Quality experiencePreferred Qualifications:5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)Bachelor’s Degree in a Science FieldAbility to oversee multiple medium complexity projects simultaneouslyWorking knowledge of quality engineering and/or mechanical engineeringFamiliar 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 teamAble to successfully manage workload to meet timelinesAbility to effectively negotiate, articulate, and defend a position after taking feedback from multiple sourcesAbility to operate in a matrixed or team environment with site, functional, and executive leadershipExperience driving decision making by using Decision, Advice and Inform (DAI) principlesUnderstanding 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 regulationsComfortable with both drug and device terminologyAbility to travel +/- 15-20% of time to domestic and international Amgen sitesWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply now and make a lasting impact with the Amgen team. careers.amgen.com.