Boston Scientific Quality Systems Engineer III 

United States, Massachusetts, Marlborough 

653436795

About the role:The Marlborough Quality Systems team is responsible for providing cross-divisional Quality Systems support through coordination of various elements within the Quality System Management and CAPA processes within the BSC Global Quality System for the Endoscopy and Urology divisions. This position provides technical guidance and leadership to Design Quality engineers and other personnel on compliance with BSC and external requirements. This is accomplished by liaising with cross functional SMEs to gather data in support of corporate and site goals, objectives and management review. This position drives a culture of continuous improvement and collaboration within the Quality systems and Design Quality groups.

Your responsibilities will include:

• Coordination and preparation of information for Management Review and ability to explain this information, when required
• Support site corrective and preventive actions process as a CAPA Mentor
• Work with project teams to create timelines, identify root cause and identify solution pathways while partnering with CAPA owners to complete phases in a timely manner.
• Analyze data as needed to ensure Marlborough site meets necessary management review metrics
• Monitor and improve site CAPA implementation aging and identify opportunities for improvement
• Develop and foster strong relationships with divisional management and key stakeholders within the Marlborough site
• Promote a culture of compliance to regulations, standards and procedures throughout the Endoscopy and Urology divisions
• Champions continuous improvement activities and identify opportunities for preventive activities for the Marlborough site
• Actively engage and participate in Communities of Practice as a Marlborough representative
• Act as a Lead or Support Auditor as necessary within the Marlborough Internal Audit Schedule.
• Support external audits and Complaint Review Board process, as required

Required qualifications:

• Bachelors degree in Engineering, Science or other related discipline
• Minimum 3 years work experience in Quality or regulated industry
• Demonstrated ability to identify and work with cross functional teams to solve problems
• Proficient MS Office suite (Word, Excel, PowerPoint)

Preferred qualifications:

• Strong organizational, analytical, and problem-solving skills with good attention to detail
• Strong interpersonal skills, ability to influence and work with others in a positive and collaborative manner
• Excellent communication and presentation skills both written & oral
• Ability to manage multiple projects
• Demonstrated ability to identify and work with cross functional teams to solve problems
• Ability to rapidly learn and use new applications

Maximum Salary: $ 151400

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

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.