What are the responsibilities and job description for the Quality Assurance Manager, Instruments position at 2010 Abbott Diagnostics Scarborough, Inc.?
JOB DESCRIPTION:
Job Title
Quality Assurance Manager, Instruments
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. You’ll 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 bachelor’s 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
Our location in Scarborough, ME currently has an opportunity for Quality Assurance Manager, Instruments is within our Infectious Disease business unit. This opportunity will ensure successful day to day operations of the designated Quality Assurance group, which includes instrument reservicing support.
WHAT YOU’LL DO
- Responsible for managing, training and supporting the work of the Quality Assurance group in their designated responsibilities within instrument reservicing and support.
- Oversees review and release of instruments for sale, ensuring compliance to regulations and Abbott policies.
- Responsible for coordinating and implementing change management activities for instrument servicing.
- May act as the Quality Assurance representative to author as well as review and approval for QIs and CAPAs.
- Continuously improves and maintains the QMS Processes, assuring compliance to applicable standards.
- Write and maintain the QMS SOPs, develop and generate relevant metrics and trending.
- Responsible for providing input into the Risk Management Process.
- Actively participates in product or process troubleshooting, and root cause analysis, by providing feedback and offering solutions that meet both business and compliance needs.
- This position may lead or participate in site projects or corporate projects.
- This position manages employees in the Quality Assurance group and carries out management and supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Required QUALIFICATIONS
- Minimum Bachelor's degree in Engineering, Chemistry, Biology, Life Science or related discipline or equivalent combination of education and experience required.
- In-depth knowledge of FDA cGMPs/QSR, IVDR and ISO Quality System Requirements.
- Demonstrated understanding of instrument manufacturing practices.
- Knowledge of Database software; Internet software; Spreadsheet software and Word Processing software.
- Ability to travel 10% of the time
PREFERRED:
- 5 years’ experience in a medical device company in a quality or regulatory function, with management experience preferred.
- Lean or Six Sigma experience preferred.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
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. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
The base pay for this position is
$97,300.00 – $194,700.00In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ID Infectious Disease
LOCATION:
United States > Scarborough : 14 Washington Avenue
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
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
Salary : $97,300 - $194,700
