Manager, Design Quality Assurance
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Job Location:
Saint Paul, MN - USA
Monthly Salary:
$ 99300 - 198700
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Job Title
Manager Design Quality Assurance
Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and 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 of which you dream.
- 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 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 around the world 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 a best place to work for diversity working mothers female executives and scientists.
The Opportunity
This position works out of our St. Paul MN (New Brighton) location in the Abbott Vascular division.
The Design Quality Assurance Manager has the broad objective of assuring the quality of design from development through manufacture and distribution for assigned products of the division. The successful incumbent will assure product designs provide necessary safety efficacy regulatory compliance and customer satisfaction while balancing the need for speed to market for new innovations as well as cost effectiveness. The ability to appropriately identify assess and mitigate risks in the design of products
can result in world-wide business interruptions multi-product/multi-batch recalls and class-action product liability claims. The incumbent will need to provide creative risk mitigation strategies to successfully deliver growth expected throughout the LRP and attain distribution margin objectives. They may lead a and set expectations against key company and department goals while delivering results.
What Youll Do
- Responsible for conducting/coordinating design reviews that provide assessment of issues risks and resource requirements for all phases of these projects.
- Manage resources to support global projects and product launches appropriately matching skill set of individual direct reports to demands of projects prioritizing efforts anticipating technical issues and assuring successful project outcome.
- Assure risks are identified appropriately characterized and managed while meeting established project schedule and cost objectives.
- Assure product/process/package designs and associated documentation comply with applicable Regulations for product
distributed in the U.S. and internationally. - Collaborate with Regulatory Affairs to establish appropriate product filing strategies and provide necessary product documentation for submission.
- Participate in Regulatory Agency inspections (FDA Ministry of Health Country health regulatory Agencies) and inquiries associated with product design change control and complaints.
- Establish and execute policies procedures processes and principles to provide robust product designs assure appropriate evaluation during development and provide necessary change control.
- Collaborate with R&D to design development test plans for new innovations.
- Establish and conduct appropriate start-up testing reconcile results and release batches for commercial distribution.
- Manage the impact of quality related design criteria on product and operational costs.
- Assure successful and cost-effective scale-up and technology transfer from R&D to commercial manufacture.
- Assure that product performance is monitored via manufacturing non-conformances and complaints.
- Identify issues investigate and implement corrective and preventative actions.
- Provide oversight of changes to plant work orders TPM standard manufacturing plans (SMP) procedures and equipment/processes as they relate to product design safety performance efficacy and testing.
- Evaluate potential acquisitions regarding quality costs identification/characterization of risks associated with quality/compliance gaps and propose mitigation strategies.
- Hire train and manage team members to address quality assurance issues across all quality functional areas.
Required Qualifications
- Bachelors Degree in Chemistry Biology Engineering or other technical discipline.
- Minimum 7 years related work experience.
Preferred Qualifications
- Medical device industry experience highly preferred.
- Verification and Validation experience.
- New Product Development (NPD) experience.
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.
Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$99300.00 $198700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
AVD Vascular
LOCATION:
United States > Minnesota > St. Paul : 1225 Old Highway 8 NW
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)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
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
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
