Supplier Quality Engineer II - External Operations Acquisition
Supplier Quality Engineer II - External Operations Acquisition
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Job Description
Recruiter: Spencer Gregory Hale
Supplier Quality Engineer II External Operations Acquisition
About the role:
The External Operations (ExOps) organization at Boston Scientific is a global passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineer will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our suppliers manufacturing this role you will support Sourced Finished Medical Device (SFMD) products within a newly acquired company within the Urology division with a primary focus on Single-Use Devices and capital equipment accessories.
Your responsibilities include:
Sustaining Engineering:
- Evaluates and communicates quality issues to suppliers and applies sound systematic problem-solving methodologies in identifying prioritizing and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
- Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
- Supports supplier audits to assess compliance with regulatory standards and Boston Scientific requirements including audit scheduling investigation and evaluation of audit observation and findings reporting follow-up and confirmation of follow-up actions.
- Manages sustaining quality issues process change impacts and design change implementations for suppliers within the Acquired Entity Quality system the hybridized BSC-Acquired Entity Quality System and in the BSC Quality System after products are successfully integrated.
- Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
- Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
- Investigates complaints and manages NCEPs at OEM suppliers and CM suppliers where the issue is manufacturing related.
- Supports Supplier Change Impact Assessments for process changes at suppliers.
- Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
- Supports projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process.
New Product Development:
- Execute initial onboarding deliverables to support initial distribution of Acquired Entitys products through BSC Distribution Centers.
- Execute SFMD Plan deliverables for integration of acquired companys suppliers and products into BSCs Quality System.
- Support the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
- Generate and review quality plans agreements product specifications component qualifications design verification/validations and process validations.
Quality System Champion:
- Supports Material Controls external regulatory body audits requests as required.
- Collaborates with corporate and regional supplier quality organizations on policy procedure and guideline development. Includes generation review and implementation of these documents.
- Identifies and advises management on potential improvements to quality systems and processes in the company.
- Champions 100% compliance to company policies and SOPs.
What were looking for in you:
Minimal Qualifications:
- BS degree in engineering or technical fieldwith 2-4 years of progressive engineering experience.
- Experience in medical device automotive aeronautical semiconductor or other regulated industry.
- Project management: ability to influence cross functional global teams spanning Quality Operations R&D and Sourcing.
- Experience in process validation design controls risk management CAPA SCAR.
- Ability to work independently; organized and self-driven.
- Articulate communicator: adept at packaging and appropriately scaling information to the intended audience.
- Ability to rapidly learn and use new software applications (e.g. PLM ERP).
- Domestic and international travel up to 25%.
Preferred Qualifications:
- Medical Device Industry experience
- Problem Solving and Project Management experience
- Leadership experience on a materials or service commodity team.
- Lead auditor of quality systems experience (ISO 13485 or similar).
- ASQ certification (CQE CBA SSGB SSBB) desired.
Requisition ID:608796
Minimum Salary:$72800
Maximum Salary: $138300
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see --will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training pertinent education including licensure and certifications among other relevant business or organizational needs. At BSC it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly) non-sales roles may also include variable compensation from time to time (e.g. any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt non-sales roles may also include variable compensation i.e. annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy the Company will continue to take steps to assure that recruitment hiring assignment promotion compensation and all other personnel decisions are made and administered without regard to race religion color national origin citizenship sex sexual orientation gender identify gender expression veteran status age mental or physical disability genetic information or any other protected class.
Among other requirements Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and as such candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
Employment Type
Intern
