Principal Quality Systems Specialist
Position Responsibilities
Quality System Management: Create and revise standard operating procedures as needed, gap analysis against the Enterprise requirements and regulations, including updates to SOP web portal and employee training. Ensure local team is following procedures and the QMS is operating effectively. Create, update and/or manage Quality Metrics. Assist with Management Review meeting preparation. Function as the site key compliance contact. Ensure the QMS is understood and followed by all team members at the MIDC site.
Audit: May create/revise internal audit and supplier audit schedules. Assist in preparations for internal and external audits. Lead or participate in audits, as needed. Support external regulatory audits.
Corrective and Preventive Action (CAPA) Management: Evaluate and triage issues that may be considered CAPAs. Communicate effectively and ask the right questions of team members and present issues clearly at CAPA Board Meetings. Actively track CAPA’s as needed and remain diligent to ensure the tasks are completed on time. As needed, assist team in developing solutions to problems and offer possible improvements to processes and systems.
Training: Responsible for preparing, conducting, evaluating and facilitating quality related training programs for employees base on the training needs and certification requirements.
Additional Responsibilities:
Years of Experience
Supplier Quality: Assist in the management of the approved supplier list. Work with team to ensure supplier qualification requirements are being followed by reviewing supplier assessments, quality agreements, and initial part qualification and supplier risk assessment documentation as required by corporate policy and RCS QMS. Visit supplier as necessary to ensure drawings and specifications are understood
Design and Development Compliance Oversight: Strong compliance oversight of the development and maintenance of the DHF for RCS development projects and products. Ensure compliance to industry and corporate standards. Actively collaborate with Quality Manager, program leadership, engineering teams and clinical/regulatory staff to ensure the Product Development Process is being followed and is operating effectively. Communicate project status to all relevant stakeholders.
Relationship Management: Acts as the MIDC site primary QMS contact for quality related topics and questions. Exercise effective influence management skills to develop and maintain positive and mutually rewarding working relationships with internal staff and external customers. Systematically implement feedback from internal and external customers to improve work processes.
Environment, Health and Safety (EHS): Evaluate and maintain the environmental health and safety support to the operations and will ensure that all practices are in compliance with Medtronic Policies. Support the development and coordination of training programs in support of EHS awareness for safe working environment across the facility.
Interface with representatives from key functional groups to drive initiatives.
Ensures appropriate resources and priorities are maintained for various projects assigned to their area.
Assist with Medtronic Corporate Quality Initiatives.
Other duties as assigned.
Minimal travel may be required based project and business needs.
Basic Qualifications
Education Required
Bachelor’s Degree in engineering or technical discipline
10-14 years’ experience in Quality compliance or Quality Management Systems or 8-11 years’ experience with MS.
With a minimum of 3+ years of the above mentioned experience in medical device and/or pharma industries.
Desired/Preferred Qualifications
Prior experience with ISO 13485 and U.S. 21 CFR 820 regulations for medical devices.
QMS auditor certification or previous auditing experience.
Strong written, verbal, and interpersonal communication skills
Strong computer skills : MS Office products and content management / quality systems-specific tools such as Documentum (QADoc), Agile, Trackwise and SABA
High attention to detail and accuracy
Experience providing guidance, coaching and/or training to other team members.
Experience working effectively across geographies and working in a cross-functional team environment
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.
EEO Statement
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:
Disclaimer
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.
