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Quality Manager II Job

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Date: Sep 11, 2021

Location: Spencer, IN, US, 47460

Company: Boston Scientific

Location: Spencer, Indiana (US-IN), United States (US)
Additional Locations: (n/a)
Hiring Manager: Adrian Crespo Llobet
Recruiter: Spencer Gregory Hale


Quality Manager II

About the role:
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.
Develops, establishes, and maintains quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to establish standards and agency guidelines to ensure lasting customer satisfaction. Reviews, analyzes, and reports on quality discrepancies related to assembly, process and product function systems and develops disposition and corrective actions for recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendors, and subcontractor representatives to determine responsibilities and solutions. May serve as liaison between the company and the various governmental agencies. Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. Establishes and ensures compliance with good housekeeping practices, employee hygiene and equipment sanitation; analyzes plant error, salvage, spoilage reports and process statistics for significant findings and conclusions; works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.

Your responsibilities include:
•    Assists in and/or manages functional deliverables and ensures technical excellence for product or technical development.
•    Establish and support a work environment of continuous improvement that supports BSC's Quality Policy, Quality System and the appropriate regulations for the area supported.  Ensure employees are trained to do their work and their training is documented.
•    Manages a team of quality engineers and technicians while also ensuring that the staff has the necessary skills to ensure compliance in their responsible areas.
•    Provides guidance and approval regarding quality strategies and approaches.
•    Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high-quality staff.
•    Assists in and/or completes the development of budgets and monitors spending.    
•    Assists in identifying and developing department tools.
•    Assists in and/or determines appropriate staff levels, schedules, and resources.  Works with project managers to understand priorities and plan resource and time allocation accordingly.
•    Performs responsibilities required by the Quality System and other duties as assigned or requested.
•    Assists in and/or manages functional deliverables to assure processes are operating at expected levels; products currently in commercial distribution conform to applicable domestic and international standards; risks associated with use of products currently in commercial distribution remain at a as low as reasonably practicable level.
•    Maintains and enhances cross-functional team relationships.    
•    Works cross-functionally in identifying and resolving technical issues.
•    Monitors and evaluates project and department progress and results.


What we are looking for in you:
•    BS in Mechanical, Electrical, Biomedical Engineering or related engineering degree
•    Minimum of 10 years in Medical device engineering experience.
•    In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
•    Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366.
•    Strong communication and presentation skills.
•    Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).

Preferred Qualifications
•    MS degree
•    12+ years medical device engineering experience 


Requisition ID: 496324

Nearest Major Market: Bloomington Indiana

Job Segment: Housekeeping, Medical, Engineer, Electrical, Quality, Healthcare, Engineering