Quality Engineer III

Boston Scientific•Spencer, IN

1d•$74,600 - $141,700•Onsite

About The Position

The Quality Engineer III provides focused quality engineering support within the Urology RCPH manufacturing core team in Spencer, Indiana. This role develops, establishes and maintains quality engineering methodologies, systems and practices that meet Boston Scientific, customer and regulatory requirements. Serving as a quality representative, this role improves awareness, visibility and communication of quality initiatives while supporting departmental, functional, site, divisional and corporate quality goals and priorities. The Quality Engineer partners across manufacturing, engineering, product, supplier and divisional teams to advance patient safety, product quality, operational excellence and continuous improvement.

Requirements

Bachelor’s degree in engineering or a related technical discipline.
Demonstrated knowledge of quality engineering principles, methodologies, systems and practices within a regulated environment.
Working knowledge of business and industry practices and organizational processes.
Experience applying structured problem-solving methodologies to investigate and resolve quality issues.
Experience supporting nonconformance investigations, containment activities and corrective and preventive actions.
Experience reviewing or supporting product, process or equipment qualification and validation documentation.
Ability to interpret, organize and communicate technical data and information effectively.
Ability to exercise independent judgment and determine appropriate solutions while working within established quality and regulatory requirements.
Ability to collaborate effectively with manufacturing, engineering, quality and other cross-functional partners.

Nice To Haves

Experience in medical device manufacturing or another highly regulated industry.
Experience with FDA regulations, ISO standards and quality system requirements.
Experience with NCEP, CAPA, PIR, complaint investigation or related quality processes.
Experience supporting manufacturing operations and product quality within a cross-functional core team.
Experience with lean manufacturing, continuous improvement or value improvement initiatives.
Experience coaching or mentoring engineering or technical team members.

Responsibilities

Provide focused quality engineering support for manufacturing operations and system/service support for Spencer RCPH (Retrievals, Catheters, Pelvic Health), partnering with Urology, PI IO&E, Endoscopy, CRM Cardiac and other Boston Scientific sites and divisions.
Provide manufacturing line support and monitor product quality to ensure compliance with established requirements.
Identify nonconformance events and initiate, own and complete NCEP records.
Determine and execute appropriate product and process containment associated with NCEP events.
Escalate CAPAs when appropriate and own and complete CAPA records.
Determine the scope of product impact during PIR ET, PIR and field action scenarios.
Partner with manufacturing engineers and product supervisors to provide leadership within the manufacturing core team.
Drive lean production and system processes and deliver measurable value through the VIP system.
Advance Protect the Core, Guardian and Delivering Excellence strategic goals, including complaint reduction, Quality Catch mitigations, workstation vulnerability score reduction, IPM improvement and preventive CAPAs.
Partner with cross-functional core team members and share ownership of deliverables related to PCA, new products, acquisition products, DCA product support, supplier engineering and supplier quality.
Collaborate with divisional Design Quality and R&D partners, serving as an internal voice of the customer across Urology, PI IO&E, Endoscopy, CRM Cardiac and other Boston Scientific sites and divisions.
Champion departmental and cross-functional engineering initiatives and serve as an effective leader or team member in supporting quality disciplines, decisions and practices.
Provide project direction, coaching and mentoring to engineering and technical team personnel.
Proactively investigate, identify and implement best-in-class quality engineering practices.
Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues, including associated risk documentation.
Review and approve product, process and equipment qualification and validation documentation, as well as other change-control documentation.
Generate internal quality documentation, including NCEP, CAPA, PIR ET and CAPA ET records; PTP and QSDP quality plans; and SOP, WI, GOI and KSD procedures.
Ensure compliance with Boston Scientific regulatory requirements, FDA requirements and applicable ISO standards across areas of responsibility.
Identify nonconformance trends in QSIG or IPM and develop technical investigation plans.
Investigate and analyze customer and internal complaints in support of the CIS lab.
Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Boston Scientific Quality Policy and all documented quality processes and procedures.
Use sound judgment to solve problems and determine appropriate actions and solutions within applicable requirements, guidelines and policies.
Organize, present and explain data and information effectively, primarily to internal audiences.
Provide coaching and mentorship to team members and peers as appropriate while remaining accountable for individual contributions and objectives.