Quality Engineer II, Auditor - Wayne NJ (Jersey City)


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

Employment Type

: Full-Time


: Accounting

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Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

Responsible for providing leadership, managing, planning, executing and reporting on regulated Quality Assurance activities for internal/external audits. This individual is responsible for performing Internal, domestic, and international audits (as appropriate) that ensure compliance with requirement such as FDA QSR, ISO, MDD and CMDR as well as other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards, as applicable. The Auditor acts as a compliance resource and provides recommendations for corrective action and tracks corrective action commitments until closure. The Auditor acts as a compliance resource and provides recommendations for corrective a Independently plans, conducts, and documents internal and external audits to assess compliance with the applicable standards and regulations and company SOPs.

Job Functions:
Plans, executes and prepares clear and concise written reports of audit or review observations, including an assessment of compliance during internal audits of facility quality systems.
Supports Quality management, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time, and that audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
Facilitates and consults with corrective action teams in implementing changes to ensure compliance with all applicable QSR/ISO//MDD/CMDR and other applicable requirements.
Performs re-audits and/or effectiveness verifications as a way of assessing and documenting CAPA Effectiveness
Issues to management timely written audit reports and follows up on audit activities to ensure appropriate corrective action.
Escalates audit findings to the appropriate level of management.
Assists during third party audits.
This is not an inclusive list of job responsibilities.

Required Knowledge, Skills and Abilities:
Bachelor's degree in Engineering or in a scientific or health-related field or equivalent is required.
ISO 13485 Lead Auditor is required.
ASQ-CQA (Certified Quality Auditor) is preferred.
Ability to prioritize and multi-task successfully in a fast paced environment
Ability to work both independently and in a collaborative team setting.

Minimum Requirements:
Minimum of three years 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.
Working knowledge of Quality Systems is required. Familiar with analytical software applications is preferred.
Project management and leadership experience is required. Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
Must have strong verbal and written communication skills and demonstrate ability to be able to interact with all levels of an organization for the purposes of gathering data and feedback for investigations.
Must have the ability to understand procedural documents and evaluate these documents to ensure compliance to all applicable regulations and requirements.
Must possess strong organizational skills and demonstrate the ability to work independently.
Ability to use Microsoft Office Products such as Word , Excel, Power Point or equivalent software applications
May require up to 20% travel both domestic and internationally.

Quality Requirements:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
Attend all required Quality & Compliance training at the specified interval.
Adopt the Beyond Compliance Quality Culture in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions:
Responsible for understanding and conforming with the Environmental Policy to ensure that significant environmental aspects that relate to actual or potential impacts with their work are executed to minimized the effects on the environment.
Responsible for bringing to the attention of management any potential improvements that could reduce our environmental impact or to report activities that could result in a negative impact to the environment.
Responsible for understanding and conforming with the Health and Safety Policy to ensure that the significant risks that relate to actual or potential hazards with their work are identified.
tion and tracks corrective action commitments until closure.

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.

We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world's most desired medtech company.

* 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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