Advanced Quality Engineer

Advanced Quality Engineer I at BD (Tissuemed Ltd)

Represent quality on design teams and assure that new and sustaining product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. Be an active team member and cross‑function collaborator on new product development and product sustaining project teams for implantable medical devices. Investigate quality complaints, examine non‑conformances and execute CAPAs.

• Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
• Develop test protocols and final reports to support Regulatory 510K, PMA, CE mark and international registrations.
• Support pre‑concept front end product innovation process activities for new technologies.
• Lead quality engineering projects to improve quality systems and procedures.
• Develop design risk assessments, coordinate input from the other design sub‑team members, and manage overall risk files for devices.
• Develop final design verification protocols and the subsequent final design verification reports including an analysis of all data and a decision on design acceptability.
• Develop design validation protocols and the subsequent design validation reports including an analysis of all data and a decision on design acceptability.
• Provide input into the project for all phases of design control documents as defined per Davol’s product development process.
• Determine the degree of biocompatibility testing with assistance from biocompatibility SMEs required as per ISO
  10993 and company procedures. Coordinate the testing and document results.
• Develop or assist in development of inspection and test methods per product specifications.
• Develop test protocols and release a final report on shelf life and stability studies in support of expiration dating.
• Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices.
• Develop shelf life and stability test protocols and reports as required.

• Develop and document the control 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 process risk assessments.
• Perform and/or support process development studies to determine the acceptability of new processes or equipment.
• Design and qualify inspection test methods and 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, and ISO
  13485:2003 requirements.
• Lead supplier part qualification activities including mold qualification and DOEs.
• Support process transfers to the production facilities.

• Organize and generate detailed quality information reports to show trends and the impact of process improvements.
• Support process transfers to the production facilities.
• Conduct other quality control projects as assigned by the manager of advanced quality engineering.
• Support the development and effective implementation of correctable and preventive action plans to resolve quality non‑conformances.
• Perform DOEs and other statistical analyses 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 department.
• Special projects as assigned.

• Bachelor’s degree in Engineering or Technical Sciences.
• 2 years minimum experience with Bachelor’s degree or 1 year minimum experience with Master’s degree in quality engineering or related discipline including design controls, product/process validation, risk management, and technical problem solving.

• High level of…