Senior Production & Process Controls Quality Systems Engineer

About the role :

The Senior Production and Process Controls (P&PC) Quality Systems Engineer will be part of our growing Global Capital Equipment (CE) Quality Assurance team supporting BSC’s high growth Medical Electrical Equipment commonly referred to as Capital Equipment (CE) portfolio.

The P&PC Quality System engineer will work closely with CE Make, Repair & Service teams globally to support them in the matters Production and Process Controls.

The role will also be responsible for actively partnering with CE Quality end-to-end process subject matter experts to allow for process congruence across CE Quality processes.

This role will allow the incumbent to be exposed to sites across the globe within BSC; and develop a global perspective and network.

The incumbent will have opportunities to understand and impact processes that directly influence BSC’s customer experience.

This position can be located in Arden Hills, Minnesota or Clonmel, Ireland.

Your responsibilities include :

• Understand BSC’s Quality System and Production and Process Controls Process.
• Partnering with Capital Equipment Make, Repair and Service sites to ensure compliance to BSC Quality System requirements and external regulations for Capital Equipment.
• Lead community(ies) or Practice for P&PC best practice sharing across all CE Make, Repair and Service sites.
• Develop an understanding of laws, regulations, standards and guidance across capital equipment / medical electrical equipment.
• Be active participant and partner in Global P&PC community of practice to identify opportunities and drive improvements.
• Key participant in Capital Equipment communities, to actively collaborate with the company’s strategy of making Capital Equipment a competitive advantage for BSC.
• Partnering with Capital Equipment Service process stakeholders to ensure compliance to BSC Quality System requirements and external regulations for Capital Equipment.
• Partnering globally to support commissioning of new service and repair sites.
• Partner with CE related acquisition teams to help them with integration strategies and operational planning for P&PC.
• Support and lead improvement projects to sustain Best4 Quality Strategy, ensuring Best Culture, Best Agility, Best Performance and Best Compliance.
• Requires strong engagement with distribution and commercial region teams to understand business requirements and help set up or improve existing Quality System processes to support the business.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to position responsibilities.
• Work across the globe with flexible working hours to support BSC teams across the globe.

Required qualifications :

• Bachelor's degree
• Experience in Medical Device Operations / Manufacturing
• Minimum of 5 years of related work experience
• Proficient in use of Excel & PowerPoint

Preferred qualifications :

• Ability to understand procedural requirements and evaluate documents to ensure compliance to all applicable regulations and requirements with focus on Production and Process Controls.
• Strong verbal and written communication, project management, and organizational skills.
• Demonstrated problem solving skills and influencing without direct authority.
• Ability to influence and indirectly lead including in challenging situations.
• Must be proactive and able to work independently with minimal supervision; strong collaboration skills are essential.

Requisition ID : 579138

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.

This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.

The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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.