Sr. Quality Systems Engineer- Global Design Controls & Labeling
About The Position
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.
Requirements
- 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)
Nice To Haves
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
