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Engineer II, Quality Job

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POST DATE 9/16/2016
END DATE 10/9/2016

Boston Scientific Corporation Marlborough, MA

Marlborough, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree



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. In the Endoscopy division, we provide advance technologies for diagnosing and treating diseases of the digestive system, airway and lungs. Medical Conditions we provide solutions for include: Malignant & Benign Tumors, Gastrointestinal Diseases, Pulmonary Diseases, Gastrointestinal Cancers and Abscesses. We are able to provide a number of solutions to patients that include: Balloon Dilation, Stenting, ERCP/Cholangioscopy, Biliary, Biopsy and Polypectomy, Hemostasis, Radio Frequency Ablation and Enteral Feeding. We have a robust product line and pipeline, and we will continue to make an investment in Endoscopy treatments.
Will develop, establish and maintain quality engineering methodologies, systems, and practices for endoscopic medical devices, which meet company, customer, and ISO and FDA requirements. Provide and improve awareness and visibility to, and communication on quality initiatives that support departmental, functional, site, divisional and corporate quality goals and priorities. Provide focused quality engineering support for commercialized products - maintaining product performance, optimizing product and processes, and driving improvement projects that meet customer and business needs. Specific responsibilities include: actively participate in departmental or cross-functional engineering initiatives; investigate, identify, and implement best-in-class Quality Engineering practices; provide technical guidance to identify and resolve quality issues; identify and implement effective design controls to support the on-going manufacturing of commercialized products to meet or exceed internal and external requirements; work with CAPA teams to resolve root cause of identified or potential product or quality system nonconformances; identify, prioritize, communicate, and resolve quality issues applying sound, systematic problem-solving methodologies using statistical analysis software programs (i.e. Minitab); support quality disciplines, decisions, and practices; support implementation of design verification and design validation of design changes for commercialized products; and support offsite manufacturing plants in maintaining product performance while driving optimization projects.

- Identifies and implements effective process and design control systems to support the on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
- Lead the implementation of design controls and CAPA systems designed to meet or exceed internal and external requirements.
- Act as team member in supporting quality disciplines, decisions, and practices.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
- Advise management on potential improvements or enhancement to quality systems and processes in the company.
BS in Engineering/Technical field.
2-5 years of technical experience
Medical device experience preferred

General office environment, with occasional domestic and international travel to other BSC facilities and or/meetings and conferences.

Familiar with the FDA, ISO, MDD and the Boston Scientific quality requirements associated with developing products in a regulated industry.
Familiar with statistical analysis software programs (e.g. Minitab)
Experience with SPC, DOE, and Test Method Validation
Experience in Risk Management Tools - FMEA, Fault Tree, Hazard Analysis
Understanding of ISO standards and FDA regulations to the manufacture of medical devices
Experience with design verification and design validation of medical devices
Experience with resolving quality issues through CAPA
Good communication (oral and written) and presentation skills.
Familiar with Microsoft Office Suite

- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.

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, CAPA, Engineering, Quality, Management