Boston Scientific
Sr. Quality Systems Engineer- Global Design Controls & Labeling
Boston Scientific, Marlborough, Massachusetts, us, 01752
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.
Responsibilities
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, 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
Boston Scientific Corporation is 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.
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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.
Responsibilities
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, 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
Boston Scientific Corporation is 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.
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