Sr. Quality Systems Engineer- Global Design Controls & Labeling at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Feb, 26

Salary

0.0

Posted On

05 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Systems, Risk Management, Design Verification, Design Validation, Design Change Process, Labeling, Localization, Medical Device Regulations, Project Management, Communication Skills, Problem Solving, Stakeholder Engagement, Quality Principles, Compliance, Product Lifecycle, eLabeling

Industry

Medical Equipment Manufacturing

Description

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 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) 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

The role involves adapting design processes for eLabeling and managing changes to support quality system improvements. The engineer will lead and collaborate with cross-functional teams to ensure compliance and efficiency in product distribution.