Abbott Manager, Quality Compliance in Minneapolis, Minnesota
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
This person manages the Quality Compliance department for the CN Division, managing the internal auditors, mentoring the lower level auditors, and providing training and opportunities for strengthening their auditing skills. This person is responsible for the internal audit process to meet the requirements of internal procedures and external regulations. This person will coordinate external, non-FDA audits and perform planning and follow up actions for external audits. This person will provide support during FDA inspections. This person will also be involved with internal audits.
Manages the Quality Compliance department.
Provides training or training opportunities for internal auditors.
Mentors internal auditors to improve their skills
Trends internal audit data.
Monitors corrective action activity for internal audit nonconformances and concerns.
Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback
Maintains a safe and professional work environment.
May conduct internal audits for the CN division
Coordinates the Notified Body and other non-FDA regulatory agency external audits
Works with facility management in preparation for the audit.
Confirms/assigns personnel to support the audit.
Coordinates audit dates with the external agency.
Supports external audits/inspections and continuing certification
Responds to non-FDA for corrective actions of audit nonconformances, assigns corrective actions internally; tracks completion of corrective actions.
Tracks external audit schedules.
Confirms the filing of pertinent documentation from external audits.
Provides support to CN facilities during FDA inspections.
Complies with U.S. Food and Drug Administration (FDA) regulations, other country regulatory requirements (Europe, Canada, Japan, Brazil, Australia, France, China, Korea, and additional countries), company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
BS/BA degree minimum.
With a BS/BA degree: minimum of 10 years’ experience in the medical device industry and 2 years auditing per ISO and/or FDA standards, including direct involvement with external regulatory audits.
With a Master’s degree: minimum of 5 years’ experience in the medical device industry and some experience in auditing, including direct involvement with external regulatory audits.
Lead Auditor Certification for ISO 13485.
Excellent writing skills and verbal skills are required.
Excellent knowledge of the following regulation areas as they pertain to quality systems: QSR, ISO, CMDR, MDD, MHLW. Knowledge of ANVISA and TGA is desired.
Experience working in a broader enterprise/cross division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
Ability to work effectively within a team in a fast-paced changing environment.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multi-tasks, prioritizes and meets deadlines in timely manner.
Strong organizational, planning, and follow-up skills and ability to hold others accountable.
Ability to travel approximately 30 - 70%, including internationally.
Ability to maintain regular and predictable attendance.
ASJM Abbott St. Jude Medical
United States > Minnesota : 5050 Nathan Lane N.
Yes, 75 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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