Biomedical Quality Assurance Engineer (Bilingual in Korean and English) (Teaneck)


: $111,680.00 - $166,760.00 /year *

Employment Type

: Full-Time


: Engineering

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Biomedical Quality Assurance Engineer (Bilingual in Korean & English) @ AccessBio (Somerset, NJ)

Basic requirement

A master degree with engineering or science major, preferably biomedical engineering or other bio-related majors

Having hands-on lab. experience with the related technical knowledge

Having a clear career goal in quality assurance and quality control in the field of medical devices

Willing to take responsibility in his/her job functions and having a positive mindset to develop and expand the person's capability to new fields

Managing given tasks not as a time-based attainment but a goal-based achievement

Solving problems and handling tasks/projects based on scientific reasoning in accordance with milestones

Handling multiple tasks systematically and promptly

Fluent in English in a way of official communication (verbal and written) with external organizations

Capable of writing technical documents based on scientific reasoning

Flexible in job functions according to his/her specialty and internal situation

Job description

Developing skills and knowledge in the field of QA/QC tasks of Access Bio

Understanding the overall work flow of QMS-related tasks of Access Bio

Managing and handling quality control tasks in detail including documentations and activities in collaboration with QC supervisors and the associate manager(s) based on in-depth knowledge and hands-on experience

- Incoming inspections

- In-process inspections

- Performance and visual inspections

- Nonconformity and related CAPAs

- Supplier controls

- Material evaluations

Establishing, reviewing and approving quality documents and records

Trend analysis of QMS-related data

Managing and conducting QMS-related lab.-works including, but not limited to, SDS-PAGE, PCR, RDT performance test evaluation.

Working and communicating closely with QA/QC staff members for system improvement of its function and effective management of Access Bio's QMS.

Providing sessions for training or introducing job-related technical topics for the development of division's capability

Arranging QMS-related training sessions for relevant divisions at Access Bio according to yearly plan.

Preparing for external and internal QMS audits and participate in the audit once qualified through the necessary training given by the team and the experience

Managing and handling quality-related complaints under the direction of the higher management

Communicating with regulatory bodies and related organizations (WHO, USFDA, other international bodies regulating medical devices) regarding QMS (GMP) management as a part of the product registration

Other QMS-related tasks given by

Associated topics: bio, biology, biophysics, medical, neuro, neuroscience, nutrition, pain, parenteral, pharmaceutical * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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