Quality Engineer II (Wayne, NJ)

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

Responsible for managing, executing, and reporting on regulated Quality Assurance activities for internal/external audits. This individual is responsible for performing Internal Audits that ensure compliance with requirements such as FDA QSR, ISO, EU MDR, MDD, and MDSAP as well as other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards, as applicable.

The position is onsite 4 days a week.

Job Responsibilities and Essential Duties

• Independently manages, conducts, and documents internal audits (and re-audits as necessary) in order to assess compliance with the applicable standards, regulations, and local documentation in accordance with the annual audit procedure/schedule.
• Supports Quality management, which includes ensuring that internal audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
• Prepares and issues within a timely manner clear and concise written reports of audit activities as well as any identified observations and/or nonconformities, including an assessment of compliance during internal audits of facility quality systems.
• Ensure that audit observations and/or nonconformities are properly investigated, documented, effective, and completed on time.
• Supports quality planning by ensuring assigned quality plans and necessary gap assessments are documented, effective, and completed on time.
• Coordinates technical activities regarding validations: including protocol development, synchronization of interdepartmental activities, evaluation, and reporting results.
• Reviews and approves product/process qualification/validation and other change control related documentation.
• Identifies and leads implementation of new opportunities for improvements to work processes, production, QA testing, and other areas as identified.
• Communicates, interacts, and coordinates quality improvement efforts with Manufacturing, QA, R&D, and engineering management regarding product status, deviations, and problems.

Minimum Requirements

• Bachelor's degree in engineering, Science or related field or equivalent is required. A Master of Science in Engineering, Science or related field is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.
• A minimum of 3 years' experience in quality assurance, quality engineering or related functions or a M.S. plus 1 year experience is required.
• Prior experience in an FDA regulated industry or ISO certified organization. Certified Quality Auditing experience conducting and participating in the Medical Device industry is required. CQA Certification is preferred.
• Prior experience in a FDA regulated industry and/or ISO certified organization. Must have strong compliance background in 21 CFR 820, 801, 803, 806 as well as ISO13485, MDD, CMDR, ISO 14971
• Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.
• Working knowledge of quality systems is required. Familiarity with analytical software applications is preferred.
• Project management and leadership experience is preferred. Previous experience supervising technicians and conducting and participating in FDA/customer/corporate audits is preferred.
• Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
• Ability to use Microsoft Office Products such as Word and Excel or equivalent software applications is preferred.

Base Salary for this position is a minimum of $88,000 and a maximim of $109,000 plus annual bonus of 8%

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About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.