Website Boston Scientific
About the role:
The candidate Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within sustaining, operational, or system/services support.
Your Responsibilities will include:
Apply sound, systematic problem-solving methodologies using defined business systems (CAPA) to identify, prioritize, communicate, and resolve quality issues
Act as an effective team member in supporting quality disciplines, decisions, and practices
Execute in streamlined business systems to effectively identify and resolve quality issues
Monitor field performance of recently launched and established medical devices against risk assessments
Lead in the quality role of a cross-functional team to identify and implement effective controls and support changes to commercialized products to meet or exceed internal and external requirements
Plan and support the verification, validation, and usability testing of changes to commercial designs to meet or exceed internal and external requirements
Partner cross-functionally to identify and support value improvement efforts to support business goals
Support product investigation report of products through competent authority communication
Support post market surveillance of products through competent authority communication
Update and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
Support medical device audits from internal or external authorities
What we’re looking for in you :
Bachelors (or higher) degree in engineering with preference mechanical engineering.
3-5 years of experience in medical device quality engineering.
Professional training and certification in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation.
Sound understanding of medical device regulatory requirements for Class II and III medical devices.
Project planning – resourcing, timelines, quality and budgets.
Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).
Preference for candidates with CQE certification or similar training and experience
Proficient in project management tools like MS project.
Experience in GD&T
Well versed with statistical analytical techniques and s/w tools like MATLAB, MINITAB.
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
To apply for this job please visit goo.gl.