Manager, Quality Manager Complaints
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Job Location:
Saint Paul, MN - USA
Monthly Salary:
$ 127300 - 254700
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.
The Opportunity
This position works out of our Abbott Park IL (preferred) or any Abbotts manufacturing location.
What Youll Work On
Our location in Lake Bluff IL currently has an opportunity for a Program Quality Manager in Complaints Vigilance and Product Actions.
The function of the Quality Program Manager is to provide corporate-level leadership and guidance for Quality Systems matters related to complaint management medical device reporting/vigilance and product actions (corrections and removals) as well as supporting other Abbott Quality System elements as it relates to post market surveillance. This includes but is not limited to providing global support to Abbott Businesses/Divisions subject matter expertise training and consultation on regulatory and compliance strategy and application. The incumbent must have a working knowledge of global regulations and industry standards especially as the relate to complaint management recalls and medical device reporting. The incumbent should also have knowledge of related Quality System elements e.g. Vigilance Reporting Risk Management Nonconformances & CAPA etc.
WHAT YOULL DO
- Use established management skills to lead global committees and teams to achieve quality regulatory compliance and business objectives.
- Act as the corporate liaison to Abbott Businesses/Divisions and provide support as an expert in the subject matter of complaints management product actions and medical device reporting.
- Remain current on regulatory requirements best practices and regulatory agency expectations to drive updates in corporate policies and procedures as appropriate.
- Participate in industry groups related to the subject matter areas of responsibility.
- Improve the effectiveness of Abbotts Quality Systems through monitoring trending and analyzing of quality data and industry intelligence information.
- Act as a change agent for incorporating best practice methods through business support activities such as remediation training coaching etc.
POSITION ACCOUNTABILITY / SCOPE:
- The scope of this position is Abbott-wide covering all Abbott Businesses / Divisions.
- This position manages multiple global projects particularly in Complaint Management and Product participation in global Adverse Event Reporting projects is also likely.
- Given the nature of the projects as they relate to regulatory and quality compliance the financial consequences for adverse regulatory findings or delayed product approval initiatives can be significant
- This position manages confidential information across the project lifecycle.
- This position requires significant interaction with executive management with accountability for assigned projects.
Required Qualifications
- Bachelors Degree required; Life or Engineering Sciences discipline preferred.
- Overall 10 years of experience with 6 years in Complaint Management and/or Corrections and removals experience in a regulated industry required.
- 4 years in Quality Assurance and/or Compliance managerial supervisory or SME role; 6 years in Medical Device Pharmaceutical and/or Nutritional industry professional-level position.
- External regulatory experience in product actions (corrections and removals) or medical device reporting desired
Apply Now
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.
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The base pay for this position is
$127300.00 $254700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
AQR Abbott Quality and Regulatory
LOCATION:
United States > Abbott Park : AP52
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 50 % of the Time
MEDICAL SURVEILLANCE:
No
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: EEO is the Law link - Espanol: Experience:
Manager
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
