Senior Supplier Quality Engineer

Boston Scientific; Indiana (PA); On-site; USD 81,000 - 153,900; Full time

Job summary

Boston Scientific is seeking a Senior Supplier Quality Engineer to drive improvement and corrective action for direct components from external suppliers. You will provide technical support in supplier selection, develop acceptance criteria for materials, and monitor supplier performance to reduce risk and improve yield.

You will collaborate with Design Quality Assurance, R&D, Regulatory, Supplier Engineering and Sourcing to lead cross-functional initiatives, mentor peers, and influence process

Qualifications

• Bachelor of Science in Engineering, Chemistry or similar technical field.
• 5+ years of relevant quality engineering experience in medical device manufacturing.
• Manufacturing Process Controls experience.
• Understanding of QSR and ISO standard requirements for Material/Purchasing Controls, Product Realization, Validation and CAPA.

Responsibilities

• Assess potential new suppliers for technical, quality and manufacturing capabilities.
• Generates and maintains incoming inspection procedures and trains inspectors.
• Analyzes incoming material defects and drives corrective action.
• Investigates field failures related to supplier materials and develops corrective actions.
• Influences cross functional global teams across Design Quality Assurance, R&D, Regulatory, Supplier Engineering and Sourcing.
• Mentors others in core Supplier Quality Engineering skills.

Skills

Quality engineering experience

Manufacturing Process Controls

QSR ISO knowledge

Cross-functional collaboration

Mentoring others

Education

Bachelor of Science in Engineering or Chemistry

Tools

ASQ Certified Supplier Quality Professional

Certified Quality Engineer

Job description

About this role

The Senior Supplier Quality Engineer drives improvement and corrective action in the quality of direct components from external suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

Your responsibilities will include:

• Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.
• Generates and maintains incoming inspection procedures - trains inspectors to these procedures.
• Analyzes incoming material defects, dispositions and drives corrective action as necessary. Communicates issues to suppliers.
• Investigates field failures related to supplier materials. Develop corrective action plan where necessary.
• Assess potential new suppliers for technical, quality and manufacturing capabilities.
• Ability to influence cross functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing.
• Anticipates potential barriers to success as well as needed resources, sees alternatives to overcome obstacles, and avoids near misses
• Mentors others in understanding of core Supplier Quality Engineering skills/competencies (Supplier Compliance, Change Control, VIP, Statistical aptitude, Quality Tools application)
• Partners with suppliers on process improvements for capability, reduction in risk, single point failures, etc.
• Generates ideas on how to expand the impact of commodity teams from cross-network customers. Understands the effects of industry and market changes on the organization
• Builds partnerships across the organization. Understands the costs/benefits/risks of pushing cross functional initiatives and makes appropriate tradeoffs.
• Is a positive image and a change agent for others internal and external to the group.
• Pro-Actively communicates effectively and ahead of supplier/customer or team needs.
• Communicates well in group settings with other departments or disciplines. Solicits inputs and involve others in decision making. Actively communicates and questions things to learn and to share ideas for improvements.
• Leads teams and projects while consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process.
• Responsible for decisions that have significant impact to the department and their customers. Follows emerging trends and educates peers in areas of expertise.

Required qualifications

• Bachelor of Science in Engineering, Chemistry or similar technical field
• 5 or more years of relevant quality engineering experience in medical device manufacturing
• Manufacturing Process Controls experience
• Demonstrated understanding of QSR and ISO standard requirements for Material/Purchasing Controls, Product Realization, Validation and CAPA

Preferred qualifications

• ASQ Certified Supplier Quality Professional or Certified Quality Engineer
• Problem Solving Subject Matter Expertise; Project Leadership Experience with Packaging, Sterilization Validation, Calibration and Analytical Labs
• Understanding of Quality Agreements
• Ability to work independently, very organized and self-driven
• Medical Device Industry expertise

Requisition ID: 631933

Minimum Salary: $ 81000

Maximum Salary: $ 153900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—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 identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specific prohibited substance test 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.