Quality Engineer II JobBoston Scientific Corporation - Spencer, IN
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Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life's work.
About the role:
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, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provide focused quality engineering support operational, or system/services support.
Your responsibilities include:
*Coordinates and conducts technical investigation and documentation of non-conforming events and corrective/preventative action. *Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. *Complies and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. *Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. *May develop mathematical models to identify units, batches or processes posing excessive failure risks. *As necessary, proposes changes in design or formulation to improve system and/or process reliability. *Utilize standard statistical analysis and problem solving techniques to determine product acceptance and evaluate process capabilities. *Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. *Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints. *Lead and support continuous improvement activities. *Must comply with requirements of ISO 14001 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards. *Establish and support a work environment of continuous improvement that supports BSC's Quality Policy, Quality System, and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented. *Develop and/or review Process Qualifications, Test Method Validations, Gage R&R's, Process Capability studies, Design of Experiment (DOE), production control plans. *Develop and/or review In-Process Inspection, Sampling Plan, product/components testing, inspection and acceptance criteria. *Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. *Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. *Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices. *Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
What we're looking for:
*Bachelors of Science degree (B.S.) and 2+ years related experience in an FDA regulated industry.
*Strong written and verbal communication skills are required.
*Training experience to FDA regulations or ISO standards *Six sigma problem solving methodologies *Proficiency in MINITAB statistical software
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
Requisition ID: 383554
9 days 21 hours ago
applyQuality Engineer II Job Boston Scientific Corporation - Spencer, IN, United States
Our products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain conditions. We continue to innovate in these areas and are extending our innovations into new geographies and high-growth adjacency markets.
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