Section Manager, QA Engineering
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Job Location:
Alameda, CA - USA
Monthly Salary:
$ 112000 - 224000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Section Manager QA Engineering
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 forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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
The Section Manager QA Engineering will both supervise engineers and technicians as well as contribute individually as Technical Design QA representative on new product design and on-market development / change teams. The Section Manager will have expertise in medical device Design Controls as well as work with RA on emerging regulations and assess impact to the designs. They will build and maintain successful cross functional relationships with internal departments such as R&D Engineering Operations Quality and Regulatory Affairs. Provide support as needed to Clinical Material Release Quality Control and Calibration programs.
This position will be based out of our Abbott Diabetes Care in Alameda CA and the individual will be expected to be onsite Monday-Friday.
What Youll Work On
The Section Manager will work on new product introduction medical device programs as well as guide the team in sustaining and design product updates. They will manage Design Control metrics equipment calibration oversight and directly supervise a team of Quality engineers and analysts.
Required Qualifications
- Bachelors Degree in Engineering or related field. Mechanical or Biomedical Engineering Degree preferred. MBA strongly desired.
- 7 yrs of experience in Quality Assurance or Engineering.
- Minimum 5 years of experience in the Medical Device Manufacturing or Pharma industry.
- Minimum 3 years direct experience in Design Control
- Minimum 5 yrs of experience in functional management experience managing direct reports.
- Must be able to lead new product development teams in addressing the technical quality issues arising for complex new diabetes care related products.
Preferred Qualifications
- Working knowledge applicable regulations and standards such as FDA QSR ISO 13485 ISO 14197 MDD and IVDD.
- Demonstrated written oral and interpersonal skills/
- Strong analytical skills problem solving techniques and statistical application experience.
- Knowledge in the areas of Medical Device and Development Design Controls V&V activities mfg practices statistical techniques.
- Experience with Class II and Class III devices.
- Sterility assurance and packaging validation experience a plus.
- Knowledge of medical product quality assurance (incl the requirement for test protocols and statistical techniques).
- Individual must be able to understand the business side of the project deliverables to ensure a realistic quality/project strategy.
- Lean Six Sigma training or certification preferred.
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.
Divisional Information
Medical Devices
General Medical Devices:
Our medical devices help more than 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 people with diabetes from routine fingersticks.
Diabetes
Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology.
The base pay for this position is
$112000.00 $224000.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
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) 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
- Embedded Software
- Section 8
- Electrical Engineering
- Employee Evaluation
- Firmware
- Systems Engineering
- Project Leadership
- Scope Management
- Team Management
- Curriculum Development
- Leadership Experience
- Mentoring
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
