Lead Engineer (Design Quality Assurance)

United States - New Jersey - Princetonlead

OtherEngineer

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Quick Summary

Overview

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare,

Technical Tools

OtherEngineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

What We Offer

~2 min read

✓Primary on-market quality assurance support for design control activities.

✓Provide guidance and direction to multi-disciplinary personnel involved in product development and production to arrive at solutions that support the company’s business objectives and quality standards.

✓Able to define document requirements for products, process and test methods verifications and validations in accordance with FDA QSR’s and specific Design Control projects activities.

✓Understanding of process, design and product/design verification/validation.

✓Able to relate information to specifications, product claims and design.

✓Uses clinical knowledge, understanding of competitor’s products, and extrapolation from limited data to assure fitness for use.

✓Responsible for implementation of design control policies and procedures.

✓Contributes to the design, development and implementation of comprehensive product assurance plans providing feedback and corrective action for engineering, manufacturing, service and field operations and suppliers performance.

✓Liaises with project and program team members on technical and quality matters.

✓Analyzing and interpreting data will be an integral part of the daily responsibilities.

✓Able to utilize data to make driven decisions and recommendations.

✓Provide and / or participate in Design Control training.

✓Responsible for review and approval of elements of Design Control including but not limited to: Planning, Device History File(s), Change Control and associated and supporting documentation.

✓May have responsibilities for review and approval of DMF, DMR, MVP, and FMEA.

✓Ensures that quality and compliance with site procedures are communicated and implemented.

Requirements

~1 min read

B.Sc. in science or engineering.
6-10 years of general work experience
4-6 years of Quality Assurance experience in medical device manufacturing or pharmaceutical industries.
Design Control Experience is required.

Knowledge of Process Validation is an asset
Membership on the American Society of Quality Control (ASQ) or Society of Reliability Engineers is an asset.
Good knowledge of quality regulations and standards, statistical calculation and measurement and manufacturing processes.
Strong knowledge of inspection methods in design, fabrication and production of electronic equipment. Demonstrated skill in using test and measuring equipment. Working knowledge of GMP, ISO standards, FDA regulations, and Health Canada.
Superior analytical and problem-solving skills and statistical applications experience.
Ability to be creativity in achieving objectives while assuring compliance with internal and external requirements.
Proven organizational and leadership skills. Ability to work under pressure in a fast-paced environment.
Excellent oral and written communication skills and ability to interact effectively with all levels in the organization.

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Operations Quality

APOC Point of Care

United States > Princeton : 400 College Road East

Standard

Yes, 5 % of the Time

Not Applicable

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work requiring repeated bending, stooping, squatting or kneeling

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