Quality Engineering Director Job

Quality Engineering Director

Requisition 81018
Category Operations-Quality
Business CardioVascular
Division CV Quality
Location USA-MA-Danvers
Relocation Relocation eligibility to be determined
Job Type Full Time - Regular
Exempt/Non-Exempt Exempt
Shift First
Travel Percentage less than 10%
Experience Required 10+ years
Education Required Bachelor of Engineering

Medtronic is an Equal Opportunity/Affirmative Action Employer


Position Description

'Leads and manages the Danvers site Quality Assurance function and as member of site leadership team responsible for assuring the control of product quality and regulatory compliance. A key requirement of role is to foster a continuous improvement culture leading the organization forward in alignment with Quality and Operations strategic objectives. As Quality Leader the incumbent is responsible for the performance management and development of the team to ensure an engaged and highly motivated staff.

Incumbent is the Management Representative as prescribed in the Quality System Regulation (QSR 21 CFR 820), ISO 13485:2003, Canadian Medical Device Regulation (CMDR) and EU Medical Device Directive (EU MDD 93/42 EEC, JPAL

Position Responsibilities

Ensure quality product is available to customer through design review, engineering, customer/vendor relations, cost reduction, inspection, environmental monitoring, product sterilization, customer complaints and MDRs.

Ensure that short and long range quality plans, goals, annual operating plans and budgets are aligned with the Quality Business System.

Monitor the Quality Business System and report to management periodically on audit results, corrective action and performance. Recommends improvements to QBS.

Resolve customer quality issues and provide technical assistance for new products.

Hire, coach, counsel, and train direct reports. Monitor performance and take appropriate action as necessary.

Plan operating budget for department and monitor performance as a component of Company profitability.

Ensure compliance with relevant safety regulations including, Quality System Regulation (QSR 21 CFR 820), ISO 13485:2003, Canadian Medical Device Regulation (CMDR) and EU Medical Device Directive (EU MDD 93/42 EEC), Quality Business System and Key Corporate Policies by subordinates.

Basic Qualifications

•BS degree in engineering.
•Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003, JPAL
•Microbiology concepts, protocols and sterilization
•Medical device industry and market knowledge
•Ten years quality assurance experience, with a minimum of eight years management experience in medical device environment
•Minimum five years commercial product release responsibility in a regulated industry
•Effective verbal and written communication skills and interpersonal skills
•Leadership skills
•Influencing skills
•Ability to manage people, departments and functions
•Human Resources skills to include interviewing and coaching
•Analytical, financial and budgeting skills
•Teaming and team building skills
•PC skills

Desired/Preferred Qualifications

•Master’s level degree in technical or business discipline
•Compliance Certification
•Quality Engineering Certification
•Broad business perspective

Physical Job Requirements

•Sit/stand eight hours
•Some travel

Nearest Major Market: Boston
Job Segments: Compliance, Customer Service, Engineer, Engineering, Healthcare, Human Resources, Inspector, Law, Legal, Management, Manager, Medical Device, Medical Device Engineer, Medical Technology, Microbiology, Performance Management, QA, Quality, Quality Assurance, Quality Engineer, Quality Manager, Science, Technology, Vascular