Job Description

• 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.

• 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.

• Project management skills
• 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 quality records
• Experience with physical method validation, qualification and transfers

• 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.
• 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.