Recruiter: Spencer Gregory Hale
Fellow Quality Systems Engineer About the role: Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provide quality engineering support within technical development concepts, new product development, operational, or system/services support. Collaborates with Quality management to recommend, design and implement functional process improvements. May mentor less experienced Quality staff, as well as other cross-functional stakeholders on implementing Quality processes and procedures as appropriate.
***This is a defined-term position***Your responsibilities include:- Applies experienced technical quality engineering principles to assigned products or sites and guides them into implementation.
- Champion departmental or cross-functional engineering initiatives.
- Provide project direction, coaching, and mentoring for engineering and technical team personnel.
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Identifies and implements effective process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
- Lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Act as leader or team member in supporting quality disciplines, decisions, and practices.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
- Advise management on potential improvements or enhancement to quality systems and processes in the company.
- Quality System Requirements
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
What we're looking for in you: Minimal Qualifications:
- Bachelor's degree in Engineering, Science, Quality, Regulatory, or a related technical discipline.
- Minimum of 10 years of quality systems, quality engineering, manufacturing quality, or regulated industry experience, preferably within the medical device industry.
- In-depth knowledge of global quality system regulations and standards, including FDA 21 CFR 820, ISO 13485, EU MDR, and other applicable regional regulatory requirements.
- Demonstrated experience leading or stewarding global quality system processes, procedures, policies, or communities of practice across a matrixed organization.
- Experience developing, maintaining, and improving quality assurance programs, process controls, procedures, metrics, and governance models that support compliance and continuous improvement.
- Proven ability to serve as a subject matter expert for quality system requirements, including interpretation of regulations and implementation of new or revised requirements.
- Experience supporting internal and external audits, including audit preparation, audit-facing subject matter expertise, response strategy, and corrective action support.
- Demonstrated ability to lead complex quality projects of significant scope, including cross-functional initiatives, strategic roadmaps, process improvements, and compliance-related projects.
- Strong written and verbal communication skills, including the ability to clearly communicate technical, regulatory, and quality system information to leadership and cross-functional stakeholders.
- Ability to work effectively across Quality, Manufacturing, Engineering, Regulatory, Supply Chain, and site/divisional teams in a highly matrixed, global environment.
Preferred Qualifications:
- Advanced degree in Engineering, Science, Quality, Regulatory, Business, or a related field.
- Extensive experience in a medical device, life sciences, or similarly regulated manufacturing environment.
- Experience as a Quality System Steward, process owner, sub-process steward, global document owner, or similar quality system governance role.
- Direct experience with one or more quality system processes such as CAPA, nonconforming materials, production and process controls, process acceptance activities, design controls, supplier quality, audits, document control, or management review.
Requisition ID: 632168Minimum Salary: $ 131700 Maximum Salary: $ 250200 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.
