Quality Assurance Manager - The Steely Group

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.

Requirements / Qualifications:

• 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.