Description:This role provides quality oversight with regards to the development and lifecycle management of test and inspection methods and fulfillment of regulatory commitments.
Potential scope of products with regards to test and inspection methods includes a wide range of devices raw material components and constituent parts such as needle protection systems fluid transfer devices pen injectors automatic pen injectors and micro-infuser delivery pump systems.
The qualified candidate will both lead and/or support technical teams to ensure successful method development or remediation and/or fulfillment of regulatory commitments provide quality oversight to one or more cross-functional teams to utilize technologies and methodologies that support short-cycle robust development accelerated compliance efforts and/or remediation/improvement opportunities.
The Quality Assurance Manager will also provide Quality oversight of quality records such as Deviations CAPAs Change controls and review/approval of physical test methods documents.
Responsibilities:
Work cross-functionally and globally with individuals and project teams within Combination Product Operations Quality and Combination Product Operations groups and their stakeholders in Marketing Operations and Development
Ensure compliance to design controls and fulfillment of user needs during test or inspection method development or design changes including proper and compliant integration of different subsystems as required.
Provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes.
Work with cross-functional teams to develop qualify and transfer physical test or inspection methods.
Provide comprehensive quality guidance and advice to counterparts and stakeholders.
Provide Quality oversight of quality records such as Deviations CAPAs Change controls and review/approval of physical test methods documents.
Skills: BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries
8 years current experience with engineering processes/procedures and quality tools. - Major contributions to or the leadership of projects from development through the 510k and PMA approval process.
Experience with material test specs generation protocol report writing process test development prototyping design verification/validation DOE/SPC process optimization validation IQ OQ PQ P/DFMEA.
Product design/development design control from concept to post product launch for Europe EMEA/CE Mark US FDA/PMA/510k submissions.
Experience in test or inspection method design and development - Small scale device assembly and/or benchtop testing experience.
Experience with Automated Test Equipment ATE. - Experience with regard to Measurement Systems Analysis/GRR principles including study design/execution/troubleshooting
Experience with Deviations CAPAs Change controls and document review/approval
Strong critical thinking problem solving risk assessment and risk management skills.
Must be capable of working on multiple projects in a deadline driven environment.
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.