Quality Operations Manager

Primary Responsibilities Include

·                  Establishes operational Quality objectives, which are reviewed by senior management.

·                  Involved in developing, modifying, and executing company policies that affect immediate operations, and may also have company-wide effect.

·                  Lead Quality Management Review process and implementation of corrections and improvements identified during the review.

·                  Lead Investigation activities (Deviations, Product Nonconformance, Investigations, CAPA activities, etc.) associated with general quality oversight, customer complaints, field alerts and/or recalls.

·                  Ensure implementation of adequate controls for producing product that meets or exceeds customer expectations.

·                  Control and disposition of nonconforming materials including Material Review Board responsibilities.

·                  Provide direction and guidance on Validation processes and tactical activities as required; review and approve validation activities when needed.

·                  Ensure that sterilizations for both ETO and Gamma Radiation activities are conducted in accordance with necessary standards.

·                  Ensures conformance to change control requirements for process and production changes.

·                  Performs special assignments and other duties as assigned.

·                  Supports internal and external audits/inspections

Required Knowledge and Skills:

·                  Strong leadership and ability to acclimate to a new environment and assess both immediate and long-term needs.

·                  Must possess exceptional communication (written and verbal) skills; effectively set priorities, lead meetings; collaborate in a team setting; ability to interact effectively with all levels of the organization.

·                  Be an independent, self-starter, detail oriented, organized and able to prioritize and balance department workloads

·                  Demonstrated knowledge of Quality in a manufacturing environment with medical device contract manufacturing companies.

·                  Knowledge in the development and review of Technical Files meeting the requirements of EU MDD/MDR, various MEDDEV guidance documents and associated standards..

·                  Familiar with sterilization methods and validation under ISO 11135 and ISO 11137.

·                  Basic understanding of clean room certifications and monitoring under ISO 14644.

·                  Ability to work cross-functionally and develop strong relationships across the business to solve both strategic and tactical issues in a manner that builds, maintains, and enhances positive working relationships and creates overall value.

Qualifications:

·                    Bachelor’s degree in a scientific discipline (i.e. Engineering, biology, chemistry) or related field preferred.

·                    A minimum of six years of experience in Operational Quality roles or assurance-related function in a regulated industry; FDA - medical device or IVD manufacturer preferred.

·                    Experience in the medical devices industry regarding medical device design, development, and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, ISO 13485 requirements and ISO 14971, Risk Management for Medical Devices; knowledge in the EU Medical Device Regulation (MDR).

·                    Experience with FDA and ISO 13485 Audits and resolution of audit observations.

·                    Professional certifications such as RAC, CQA, CQE or CQM/OE desirable.

Requirements and Physical Demands:

·                    Travel:  Travel 15% - Must be able to travel by car/air to other locations as needed.

·                    Physical:   Must have the ability to lift up to 25 pounds of supplies or finished product throughout the work shift.

·                    Must be able to wear personal protective equipment (latex or nitrile gloves, safety glasses/face shields, etc.) when on the manufacturing floor.

·                    Sitting and working at a computer workstation for long periods of time.