Sr. Quality Engineer

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Job Description

The Sr. Quality Engineer is responsible for supporting Product Lifecycle Management and Design Quality Assurance within the Infection Prevention Platform. The incumbent works multi-functionally with teams on change management projects (including those that may impact product design), design transfers, global expansion projects, risk management, process/product design and development, quality improvement projects (QIPs), and cost to win (CTW) projects.

General Functions, Specific Responsibilities, and Authority

The Sr. Quality Engineer works closely with shared functions (e.g. Regulatory Affairs, Designated Complaint Handling Unit (DCHU), Sterility Assurance, etc.), as well as R&D, Manufacturing, Sales, Marketing, Operations, Supply Chain, and Finance.

The Sr. Quality Engineer interacts with Regulatory Affairs regarding new regulations and standards as they apply to product change regulatory submissions and regional expansions, with DCHU on complaint handling/resolution and field actions pre-/post - product launch, Packaging COE on new product packaging projects and changes, Sterility Assurance on sterilization process (re) validations and with Platform Management regarding product design and development, as well as design transfer activities.

Product Quality and Lifecycle Management:

* Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.

* Lead Quality Engineering Projects to improve Quality systems and Procedures.

* Support or leads change management activities including risk and design impact assessments.

* Update and maintain product Design History File (DHF) & Drug Master File (DMF) based on change activities.

* Development and maintenance of the Risk Management File in accordance with ISO
14971, coordinating input from the other Design Sub-team members including the development of the design, process, and usability FMEAs.

* Develop or assist in development and qualification of inspection and test methods and equipment.

* Develop and document the Control Plan / System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product.

* Support the development of manufacturing control plans for internal and outsourced processes.

* Support (or lead) development of the PFMEA, Process Requirements Specifications (PRS), and Validation Plans and Protocols including developing statistical sampling requirements.

* Perform and/or Support Process Development Studies to determine the acceptability of new processes or equipment.

* Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21

CFR 820, 210, 211; cGMP's, CMC, and ISO
13485 requirements.

* Lead supplier part qualification activities including mold qualification and DOEs (PPAP).

* Support Design / Process Transfers to the Production facilities as well as line expansion / capacity / productivity changes.

Other:

* Supports new global expansion efforts for existing products.

* Liaison between OUS quality and plant quality.

* Support the disposition investigation and decisions of rejected nonconforming components and products; conduct MRB action when required.

* Organize and generate detailed quality information reports to show trends and the impact of process improvements.

* Conduct other Quality Control Projects as assigned by the Manager of Quality Engineering.

* Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances.

* Perform DOE's and other statistical analysis to support product and process optimization or determine causes of process variation. Initiate corrective actions as required.

* Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.

* Support goals of the Quality Assurance / Engineering Department.

* Mentor junior QE staff

Knowledge, Education, and

Skills Required:

* Bachelor's degree in Engineering from an accredited four (4) year university.

* 5 - 8 years Quality Engineering experience with pharmaceutical, combination products, or medical devices.

* Pharmaceutical or combination product experience, preferred.

* ASQ Certified Quality Engineer (CQE), Six Sigma Black Belt (SSBB), or advanced degree preferred.

* Experience operating in GLP, GMP, and GDP.

* Knowledge of statistics and experience with statistical software (e.g. Mini Tab), preferred.

* Experience with ERP systems and software such…