Quality Engineer III

Boston Scientific•Spencer, IN

5d•$74,600 - $141,700•Onsite

About The Position

This role provides focused quality engineering support within the Core Endo manufacturing core team. The position develops, establishes and maintains quality engineering methodologies, systems and practices that meet Boston Scientific, customer and regulatory requirements. The role serves as a quality representative to improve awareness, visibility and communication of quality initiatives while supporting departmental, functional, site, divisional and corporate quality goals and priorities. It also provides focused quality engineering support for operational, system and service needs supporting the Spencer RCPH — Retrievals, Catheters and Pelvic Health — organization, including Urology, PI IO&E, Endoscopy, CRM Cardiac business divisions and other Boston Scientific sites. This is an on-site role requiring employees to work at the Boston Scientific Spencer site in alignment with business and team needs.

Requirements

Bachelor’s degree in engineering or related field
Minimum of 3 years' experience in a related role
Experience with process validation and verification activities and risk management documentation, including design and process FMEAs.
Knowledge of analytical techniques and statistical analysis.
Knowledge of basic quality systems and good documentation practices.

Nice To Haves

Demonstrated experience managing multiple projects across diverse engineering disciplines, including software, hardware and labeling.
Experience in the medical device industry
Self-starter with the ability to identify improvement opportunities.
Experience leading cross-functional teams and driving projects to completion.
Experience interacting with manufacturing engineering, post-market complaints, CAPA, risk management, supplier quality and process engineering functions.
Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint and Outlook.
Familiarity with product and component documentation, inspection and testing, and manufacturing execution systems (MES).

Responsibilities

Provide manufacturing line support and monitor product quality.
Identify nonconformance events and initiate, own and complete NCEP records.
Determine and execute product and process containment activities associated with NCEP events.
Escalate CAPAs as appropriate and own and complete assigned 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 core team.
Drive lean production and system processes and generate value through the VIP system, including measurable return on investment.
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 partners in Design Quality and R&D, serving as an internal voice of the customer across Urology, PI IO&E, Endoscopy, CRM Cardiac business divisions and other Boston Scientific sites.
Provide leadership for 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 requirements and applicable FDA and ISO requirements across assigned areas of responsibility.
Identify nonconformance trends through QSIG or IPM and develop appropriate technical investigation plans.
Investigate and analyze customer and internal complaints in support of the CIS lab.