Sr. Supplier Quality Engineer - Drugs Categories

Recruiter: Spencer Gregory Hale

Sr. Supplier Quality Engineer – Drugs Categories

About this role:

The Supplier Quality Engineer will play a key part in leading performance improvement of active pharmaceutical ingredients (API), excipient suppliers and increasing the supplier's capabilities to consistently meet Boston Scientific's requirements. Additionally, the Supplier Quality Engineer will support global sourcing, manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects. The North America MN Supplier Quality Engineering team is looking for high-energy, driven, passionate people, looking to not just change jobs, but start an amazing career!

In this role, you will drive improvement and corrective action in the quality of components sourced from outside 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:

• Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling, investigation, and evaluation of audit observations and findings, reporting, follow-up, and confirmation of follow-up actions. Proactively assesses supplier capabilities through direct on-site visits and technical discussions and supports the evaluation of proposed changes at suppliers.

• Develops solutions to complex problems by evaluating data and selecting methods within defined practices and policies. Communicates quality issues to suppliers, applies systematic problem-solving methodologies, and reviews and approves supplier corrective action plans and effectiveness documentation.

• Actively engaging in Global Sourcing category teams as a technical lead, establishing and executing Global Sourcing category objectives

• Leads cross-divisional and cross-functional projects that deliver improvements to quality systems and processes.

• Works under minimal direction regarding the direction and progress of projects and special assignments. Independently determines and develops innovative approaches to solutions. Interprets, executes, and recommends modifications to the Quality Management System. Provides leadership and mentorship to junior engineers. Work is reviewed upon completion for adequacy in meeting strategic objectives and alignment with company goals.

• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represent a specialized field in larger project teams. Influences middle management on business solutions.

• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures. Ensure that appropriate resources, including personnel and tools, are available to support Quality System compliance and adherence to the Quality Policy. Foster a work environment that upholds the Quality Policy and Quality System.

What we're looking for in you:

Minimum requirements:

• BS degree in Chemistry, Biochemistry, chemical engineering or similar with minimum of 5 years of relevant experience.

• Experience in pharmaceutical or drug combination products and Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

• Strong knowledge of FDA 21 CFR 820 and CFR 210/211.

• Communicates effectively and concisely pack up information to deliver key points; appropriately scales communication style and depth according to the audience.

• Ability to influence cross functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing.

• Builds strategic and trusting relationships through demonstrated technical capability, critical thinking, and teamwork behaviors.

• Ability to work independently and collaborate with project teams; organized and self-driven.

• Ability to work in a matrixed environment.

• Travel up to 10% of the time.

Preferred Qualifications:

• Experience in global supplier management, ISO 13485, ISO 9001 strongly desired.

• Experience with manufacturing support or process development.

• Experience with project management.

• Ideally someone with experience in aseptic processes.

Requisition ID: 633004

Minimum Salary: $ 85000

Maximum Salary: $ 161500

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.