Medtronic Sr Quality Systems Manager in Mansfield, Massachusetts
Sr Quality Systems Manager
Minneapolis, Minnesota, United States
Jun 10, 2021
Bring your talents to an industry leader in medical technology and healthcare solutions were a market leader and growing every day.At Medtronic Renal Care Solutions (RCS), we are working on new therapies for End Stage Renal Disease. Our RD team spread across US, Italy, India, and China is working on innovative dialysis solutions that would expand clinical access to thousands of patients worldwide. The RCS Operating Unit is looking to hire a talented and motivated quality individual to join our Quality leadership team.
Careers that Change Lives
A Day in the Life
The Sr Quality Systems Manager is responsible for maintaining and improving the Quality Management System at the RCS Operating Unit. The responsibilities include reviewing and revising QMS policies and procedures to ensure the work conducted conforms to established corporate standards and industry regulations/standards. The individual will be instrumental in supporting the direction and plans for process improvement and ensuring the sites are audit ready. Additionally, the Sr QMS Manager will lead global team members and programs. The individual will be point of contact for Quality for the RCS US, bringing new dialysis systems to market.
POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES AS ASSIGNED:
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.
Lead a team with experienced professionals across multiple geographies, including development of strategy and objectives
QMS responsibilities include but are not limited to: Quality Manual, Quality Management Review, Quality Planning, Training, Supplier Quality, Internal/External Audit, Change Control, and Design and Development
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Prepares reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
Co-ordinates legal requests in support of government investigations or litigations.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Initiates programs or projects based on identified business and / or tactical needs.
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of companys mission globally.
Supports and maintains an environment that fosters communication and teamwork.
Possess the ability to work independently and prioritize workload with minimal guidance and supervision.
Comfortable interacting with others as this role may interface with others within functional groups in order to ensure quality objectives are being met.
MUST HAVE: MINIMUM REQUIREMENTS:
Prior experience with ISO 13485, EU MDR and U.S. 21 CFR 820, 21 CFR 211, 21 CFR 210 regulations for medical devices and pharma products.
Strong written, verbal, and interpersonal communication skills
Ability to utilize past medical device experience to coach team members and provide the team guidance on where challenges may exist for medical device development.
- Bachelors Degree in Engineering, Technical Discipline, or related
YEARS OF EXPERIENCE:
SPECIALIZED SKILLS OR EXPERIENCE:
Bachelors degree or equivalent and minimum of 7 years of relevant experience with 5+ years of managerial experience
Advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience
NICE TO HAVE
Ability to create, lead, establish, maintain and influence effective working relationships with internal customers at all levels.
Ability to work collaboratively across different countries, cultures and time zones.
Ability to build credibility, establish rapport, and maintain communication.
Strong computer skills : MS Office products and content management / quality systems-specific tools such as Documentum Agile, and Cornerstone
High attention to detail and accuracy
Certified Quality Manager, Engineer, or Auditor or previous auditing experience a plus.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
Physical Job Requirements
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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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.
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