Sr Quality Systems Manager

Medtronic Inc.
North Haven
Mar 06, 2018
Mar 09, 2018
Employer Type
Direct Employer
Employment Type
Full Time
Careers That Change Lives

Your dedication to quality is important to our customers and, most importantly, to their patients. As an important member of Quality team in Manufacturing you will be a key Operations representative within the Advanced Surgical Technologies (AST) team.

Do meaningful work, make a difference, and improve lives ? starting with your own.

The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

SURGICAL INNOVATIONS sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

A Day in the Life

You will plan, direct and monitor Quality Assurance (QA) activities to ensure that components and finished products are processed in accordance with internal and external policies and procedures to produce devices that meet specifications and satisfy the customer. You will partner with the Focus Factory management team to achieve team and company goals. You will ensure that the Focus Factory operates in a state of compliance with internal policies and procedures as well as domestic and international regulations and standards (e.g. FDA, ISO, MDD).

You will provide leadership and technical support for plant and company product, process, or design improvement projects, leading and directing quality system improvement programs in the plant.

Reports to North Haven QA Director. Direct reports include Quality Managers, Quality Engineers and Quality Supervisors and Technicians.

You will:

* Act as the Focus Factory Quality Representative and conduct all Focus Factory Corrective Action Boards.

* Establish and implement a Quality System that complies with domestic and international quality system requirements and guidelines.

* Evaluate compliance of raw materials and processed product with specifications and customer requirements.

* Develop and implement a continuous improvement program for product quality.

* Review and approve process and product changes notices.

* Lead Product Release

* Ensure Document Control requirements are maintained

* 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 standards and agency guidelines.

* Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.

* Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet 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.

* Co-ordinates legal requests in support of government investigations or litigations.

* Ensures the quality assurance programs and policies are maintained and modified regularly.

* Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Must Have: Minimum Requirements:

Bachelors degree in Science or Engineering plus 7+ years of related experience with 5+ years in a leadership role in QA/manufacturing environment in a medical device company or other regulated, critical end-use product industry, mechanical assembly and chemical manufacturing processes. Or an equivalent combination of education and experience which provides the skills and abilities needed to perform the duties of the job.

* Demonstrated analytical and data based decision making skills, statistical sampling and analysis and proficiency with Minitab statistical software. CQA/CQE

* Knowledge of medical device regulations, a plus.

* Strong oral and written communication, computer (Word, Excel and Powerpoint).

* Strong organizational skills.

* Ability to define problems, collects data, establish facts and draw valid conclusions.

* Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

* Ability to effectively present information to large groups.

* Good communication skills (presentation, written, and oral). Proven leadership skills.

* Must be able to recognize and support plants performance and priorities.

* Advocate a team concept. Proven ability to motivate personnel in order to balance staffing strength with profitability and growth.

* High energy level, capable to handle multifaceted projects in conjunction with normal activities.

* Well-developed interpersonal skills; ability to get along with diverse personalities.

Nice to Have:

Master's Degree

Six Sigma Black Belt and/or Lean Manufacturing certification


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.


The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:


The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. SDL2017