QA Engineer - Process Control at Abbott

Hangzhou, China

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Medical DevicesIndustries

Requirements

Bachelor Degree and above in related discipline or Diploma
3+ years’ quality experience in pharmacy or medical devices industry
Familiar with regulation codes: ISO9000, ISO13485, GMP, 21CFR820, IVDD, IVDR, <Regulation for Quality Management of Medical Device Production>, etc
FDA audit experience preferred
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage and/or engage others to accomplish projects
Strong organizational, communication, and coordination skills, as well as attention to detail

Responsibilities

Track, maintain, and analyze batch records; cooperate with cross teams for improvement opportunities and coordinate finished product release
Monitor manufacturing process to catch issues during production; communicate with cross functions for troubleshooting from a quality standpoint, ensuring compliance
Perform online quality management for production; develop procedures to guide new issues based on actual production
Conduct online monitoring for manufacturing shop floor GMP, supporting and following improvements
Coordinate with cross departments (e.g., work order, manufacturing, packaging) for troubleshooting
Individually evaluate the impact of finished products and act as a decision maker
Perform external document assessment
Observe issues independently and troubleshoot using quality tools like RCA and 5WHY
Undertake other quality assurance responsibilities

Skills

Key technologies and capabilities for this role

Batch Record ReviewGMPQuality AssuranceRCA5WHYISO9000ISO1348521CFR820FDA AuditProcess MonitoringTroubleshootingCross-Functional Coordination

Questions & Answers

Common questions about this position

What is the location for this QA Engineer position?

The position is located in Hangzhou, China at #198 12th Street, Hangzhou Economic & Technological Development Area.

What is the base pay or salary range for this role?

The base pay for this position is listed as N/A, and in specific locations, the pay range may vary from the range posted.

What qualifications and experience are required for this QA Engineer role?

A Bachelor Degree or above in a related discipline or Diploma is required, along with 3+ years’ quality experience in pharmacy or medical devices industry, and familiarity with regulations like ISO9000, ISO13485, GMP, 21CFR820, IVDD, and IVDR.

What skills are needed to succeed in this position?

Strong organizational, communication, and coordination skills, as well as attention to detail, are required, along with the ability to work in a highly matrixed environment, within teams or individually in a fast-paced setting.

What makes a strong candidate for this QA Engineer role at Abbott?

Candidates with FDA audit experience, proficiency in quality tools like RCA and 5WHY, and the ability to independently observe issues, troubleshoot, and make decisions on product impact stand out.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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