Quality Assurance Manager - Pharma/Medical Devices

Job Description Job Description Title: Quality Assurance Manager Location: Cambridge, MA Duration: 12 months Description: 100% Onsite AMA M-F (8am

• 5:00 pm, flexible) 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 Final Product Technologies Quality and the Final Product Technologies Engineering 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. Top 3 Must Have Skill Sets: Experience in Pharma/Biotech background and quality assurance (minimum of 5-10 years) Experienced with processes involved in test, inspection for a wide range of devices, raw material components, constituent parts (needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. Experience with physical method validation, qualification, transfers; quality management systems Day to Day Responsibilities: • Work with a cross functional team to ensure compliance to design controls and fulfillment of user needs • Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods • Review and approve physical test method design documents, validation, qualification and transfer documents • Review and approve quality records (deviations, CAPA/EVs, change controls) • Lead problem solving and lean improvement projects Employee Value Proposition: Career growth, opportunity, networking, experience Possible Extension: Yes Company Description Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years. Company Description Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.