Recruiter: Spencer Gregory Hale

Senior Quality Systems Engineer- Global Design Controls & Labeling

About the role:
BSC is re-imagining the way our products are sourced, manufactured, packaged, shipped and distributed. This new approach will allow us to manufacture more products and reliably deliver them to customers, while making our supply chain more sustainable by lowering carbon emissions, reducing packaging waste and significantly decreasing our global shipping footprint.

These advances will result in part from postponing product packaging until we determine the product's final destination. Where possible, products will be directly shipped to customers. For products headed to countries where regulations allow electronic Instructions for Use (IFUs), we are eliminating paper IFUs and shipping devices more fuel efficiently in lighter packaging. Where printed IFUs are required, we only send instructions in local languages, rather than in multi-lingual packets.

To enable this transformation, we need a quality system – design activities/risk management Subject Matter Expert to develop and build out the new connections across processes in our Quality System that ensure we execute in a compliant and sustainable manner.

This is a unique opportunity to shape how BSC operates on a day to day level, and be part of the movement that is going to change the way we deliver products in the years ahead.

Your responsibilities include:

• Adapting the BSC Design processes to facilitate the transition to eLabeling, with an emphasis on changes and guidance in the following spaces:
• Risk Management
• Design Inputs
• Design Outputs
• Design Verification and Validation
• Design Change Process
• Backwards Compatibility
• Labeling and Localization
• Acquisition
• Sourced Finished Medical Device (SFMD)
• Documentation, specifically DMR for a single UPN with many global variants
• Product Lifecycle Process (PLCP)
• Managing change to develop divisional and cross-functional community support for proposed Quality System changes
• Understanding how Quality System changes impact and support distribution of product across our global marketplace
• Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices
• Ensuring the development and execution of streamlined business processes which help achieve VIP/Continuous Improvement goals
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Influencing key stakeholders through collaborative community engagement
• Help to connect the key SMEs across divisions and capitalize on networking skills to promote best practice sharing and efficient problem solving
• Supporting internal and external audits and audit responses

Required Qualifications:

• Bachelor's degree in Science, health, packaging and labeling, or engineering
• Minimum of 7 years of Medical Device experience required
• Understanding of US and International regulations including 21 CFR 820, and ISO 13485; ISO 14971 and the European Union Medical Device Regulation, EUMDR.
• Experience in quality system process development
• Experience in design activities/risk management including design inputs/outputs, design verification and validation, design change
• Familiar with Microsoft Office Suite (Excel, PPT, Word)

Preferred Qualifications:

• Strong communication (oral and written) and presentation skills
• Strong project management skills
• Broad understanding of Quality principles and strong understanding of compliance
• Ability to translate external requirements into new processes without sacrificing compliance or efficiency
• Ability to work in the grey space, and develop innovative solutions to complex challenges
• Ability to see how individual processes interact within the context of the entire product lifecycle from initial concept through final usage
• Experience in product labeling

Requisition ID: 617150

Minimum Salary: $ 86600

Maximum Salary: $ 164500

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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.

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.

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.