Engineer, Sr Quality Job
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PRIMARY LOCATION: US-MA-Marlborough
ADDITIONAL LOCATIONS: (n/a)
REQUISITION ID: 285914
UROLOGY AND PELVIC HEALTH At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. The Urology and Pelvic Health business unit provides proven, leading solutions to treat kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), male incontinence and pelvic floor disorders - more urology subspecialties than any other company. In addition, we continue to invest in gynecologic surgical solutions for the treatment of abnormal uterine bleeding and uterine fibroids. These offerings can help healthcare providers advance patient outcomes, reduce procedure costs and enhance quality - enabling millions of men and women to regain control of their lives. We have a robust product line and pipeline, and we will continue to make an investment in Urology and Pelvic Health.
- Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
- Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for implementing product stops & documenting release criteria.
- Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analysis, FMEAs in conjunction with other product development team members. May be responsible for risk analyses and FMEAs.
- Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
- Collects and analyzes Leads Manufacturing process defect data Product/Process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development
- Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
- Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned. BASIC QUALIFICATIONS
BS in Mechanical, Electrical, or Biomedical Engineering; MS strongly preferred. Minimum of 7 years of Medical device engineering experience; 7 + years of medical device engineering experience preferred.Minimum of a BS in Mechanical, Electrical, or Biomedical Engineering; MS strongly preferred.
Boston Scientific is an Equal Opportunity Employer.
Posting Notes: US-MA-Marlborough||(n/a)||Quality||(n/a)
Nearest Major Market: Boston
Job Segment: Quality Engineer, Manufacturing Engineer, Engineer, Senior Quality Engineer, Engineering, Quality