Sr. Quality Engineer, Internal Audit (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

This position is 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 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 Auditor acts as a compliance resource, and provides recommendations for corrective actions and tracks corrective action commitments until closure.

This position is onsite 4 days a week.

Job Responsibilities and Essential Duties

• Independently plans, conducts, and documents internal and external audits to assess compliance with the applicable standards and regulations and company SOPs.
• 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 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.

Required Knowledge, Skills, and Abilities

• Bachelor's degree in Engineering or in a scientific or health-related field or equivalent isrequired.
• Minimum of five years' experience with 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.
• ISO 13485 Lead Auditor is required.
• 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 prioritize and multi-task successfully in a fast-paced environment
• Ability to work both independently and in a collaborative team setting
• Ability to use Microsoft Office Products such as Word, Excel, Power Point, or equivalent software applications

The base salary for the position is a minimum of $112,000 and a maximum of $120,000 plus annual bonus of 10%

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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.