Assoc. Quality Engineer
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What you'll do
- Support project planning and perform assessments and mitigations with cross functional teams.
- Develop and manage training programs including training material and training audience.
- Track and report metrics.
- Provide support to internal and external audits.
- Manage relevant audit findings and CAPAs.
- Continuously improve processes to align with current and emerging regulatory and customer requirements and best industry practices.
- Collaborate with AV key stakeholders, Abbott corporate functional groups and other Abbott business units.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Independently, or lead a project team to, identify, plan and conduct medium-size assigned projects requiring a combination of conventional and custom risk-managed execution plans and investigations.
- Lead technical projects with inter-coordinating elements where problem resolution may involve the application of new methods and/or approaches and may require consideration of impact with other system components and/or users.
- Lead and/or participate on cross-functional teams to support organizational goals.
- Responsible for completing documentation in a timely manner and in accordance with business standards.
What they're looking for
- Bachelor's degree (Engineering/Life Sciences)
- 2-5+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience.
Nice to have
- CAPA experience
- Strong technical knowledge and application of concepts, practices and procedures.
- Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
- Ability to form and develop interpersonal, professional relationships.
- Display socially and professionally appropriate behavior.
- Ability to work independently and in groups.
- Ability to work cross-functionally.
- Demonstrated initiative and problem-solving skills.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
JOB DESCRIPTION:
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. 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 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 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
Our location in Temecula, CA, currently has an onsite opportunity for a Quality Engineer. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents
Provide Process/Quality Engineering support on the manufacturing line, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
What You’ll Work On
Support project planning and perform assessments and mitigations with cross functional teams. Develop and manage training programs including training material and training audience. Track and report metrics.
Provide support to internal and external audits. Manage relevant audit findings and CAPAs.
Continuously improve processes to align with current and emerging regulatory and customer requirements and best industry practices. Collaborate with AV key stakeholders, Abbott corporate functional groups and other Abbott business units.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Independently, or lead a project team to, identify, plan and conduct medium-size assigned projects requiring a combination of conventional and custom risk-managed execution plans and investigations. manages multiple often concurrent projects.
Lead technical projects with inter-coordinating elements where problem resolution may involve the application of new methods and/or approaches and may require consideration of impact with other system components and/or users.
Lead and/or participate on cross-functional teams to support organizational goals.
Responsible for completing documentation in a timely manner and in accordance with business standards.
Serve as a subject matter expert (SME) on a subset or select subsets of a project's technical matters. may interface with external firms or agencies.
Responsible for implementing the effectiveness and maintaining compliance of the Quality System. (e.g. compliance with internal procedures and FDA, BSI regulations etc).
Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
Assists with evaluating project costs.
Identifies, develops and implements processes to improve department performance.
Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
Required Qualifications
Bachelor's degree (Engineering/Life Sciences)
2-5+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience.
Preferred Qualifications
CAPA experience
Strong technical knowledge and application of concepts, practices and procedures.
Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.
Ability to form and develop interpersonal, professional relationships.
Display socially and professionally appropriate behavior.
Ability to work independently and in groups.
Ability to work cross-functionally.
Demonstrated initiative and problem-solving skills.
Critical-thinking skills.
Ability and aptitude to use various types of databases and other computer software.
Ability to prioritize.
Strong organizational and project management skills.
Demonstrated competency with financial systems and in fiscal controls.
Ability to quickly gain knowledge, understanding or skills and is willing to learn.
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
$61,300.00 – $122,700.00In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
AVD Vascular
LOCATION:
United States > Temecula : Building E - TE
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % 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: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Company
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