Manufacturing Operations Quality Assurance Manager

Medtronic•Tempe, AZ

1d•Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will lead Tempe Operations Quality Assurance. Areas of the Quality Operation under this role include Incoming and Receiving, product acceptance on all site value streams and controlled environment compliance for all site cleanrooms. This is an Operations/Quality focused role in support of Medtronic's Tempe Manufacturing plant. This role will also be expected to represent the Tempe site in external and internal audits. As the Manager for this group, you will be responsible for ensuring the compliance of both incoming and outgoing components and products to ensure that Medtronic meets all regulations, customer requirements and above all ensures the safety and reliability of our products for our patients.

Requirements

A bachelor’s degree is required
5+ years of relevant experience or advanced degree with a minimum of 3+ years prior relevant experience
Experience in medical device manufacturing in either a Quality Engineering or Manufacturing Engineering role.
Demonstrated experience or ability to lead teams with a focus on coaching, continuous improvement and management by objectives
Experience with medical device regulations and ISO 13485 as well as experience in medical device manufacturing and product acceptance.
Experience with audits from regulating/certification bodies including front room experience.
Demonstrated ability to work in an Operations leadership role supporting a 24/7 production environment.
Demonstrated ability to work cross functionally including across Quality functions at the site and across Operations, Facilities, Development, and other functions within the site.
Hands on manager that leads by going to the Gemba to understand issues and opportunities for improvement.

Nice To Haves

BS degree in related Engineering field is strongly preferred
Experience running a front room for FDA or other regulatory/certification audits
Experience with implementing and managing acceptance testing methods
Work experience as Quality Engineer or Manufacturing engineering in medical device manufacturing
Previous management experience
Lean Sigma Green Belt or Black Belt
Experience managing controlled environment compliance for medical devices or electronics manufacturing
Experience with controlled environment compliance is a plus.
Experience and understanding of electronics manufacturing processes and components used in electronics manufacturing.
Lean Sigma experience and MPS (Medtronic Performance System) for Medtronic candidates.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

Leads a manufacturing site to excellence in product quality, operational excellence, and a culture of putting patients first.
Drives the combined Quality and GOSC strategies to deliver results.
Interacts with and influences leaders across multiple leadership teams (Core Quality, OUs, and GOSC).
Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
May develop, evaluate, implement, and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.

Benefits

Medtronic offers a competitive Salary and flexible Benefits Package
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)