Sr. Quality Product Engineer - Post Market (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

The Sr. Quality Product Engineer is part of the QE - Product Development team and is responsible for ensuring the product meets the highest quality standards throughout the development lifecycle and post market. This role involves working closely with the cross-functional product engineering team to identify and mitigate risks, implement quality controls, and ensure compliance with industry regulations and standards. Specifically, this role will be responsible for post-market oversight on the products to ensure that health hazards are evaluated based on reported complaint trends and manufacturing non-conformance, support their investigation, and present the investigation findings to support appropriate field action decisions. For initiated field actions, this role will maintain an oversight of field action execution providing regular status update to the leadership and track progress of associated CAPAs. Will maintain Field Action Plan to reflect the current status of a solution (if applicable) via associated CAPA and ensure appropriate updates.  Responsible to develop, improve and implement quality processes, conduct risk assessments, and ensure compliance to design controls requirements. The Sr. Quality Product Engineer will also support continuous improvement initiatives and contribute to the development of quality assurance processes and documentation.

The position is office based 4 days a week.

Job Responsibilities and Essential Duties

Health Hazard Evaluations:

• Perform health hazard evaluations to assess the potential risks associated with post-market issues.
• Collaborate with cross-functional teams, including medical, regulatory, and engineering, to determine the appropriate course of action.
• Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee. 

Field Actions:

• Develop and implement field action plans, including recalls, corrections, and removals, ensuring compliance with global regulatory requirements.
• Track and document the progress of field action plans, ensuring timely completion and effectiveness.
• Track and respond to various inquiries from Regulatory Authorities on cause and status of field action, ensuring a cross functional collaboration where needed.
• Responsible to maintain and update the Field Action Plan to ensure any activities that impact planned closure date are appropriately escalated or rationalized to revise the closure dates.
• Responsible for reporting on Field Action progress to business leadership via monthly status updates, Management Review, and other forums as needed.

CAPA:

• Oversees progress of CAPAs that are initiated to address Field Action issue. Ensuring root cause analysis and corrective actions adequately minimize the field action issue.
• Support CAPA Owners and/or lead CAPA activities in all phases of the CAPA process.
• Monitor CAPA implementation and verify the effectiveness of actions taken.

Product Design Changes:

• Ensures assigned design change initiatives (design changes that will help address product issues for which field actions are initiated) are executed in accordance with Design Controls procedural requirements. Ensure compliance with ISO 13485, ISO 14971, FDA 21 CFR Part 820, EU MDD, EU MDR and other relevant regulations and standards.
• Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, code review, and unit test inspections. Especially when such changes impact the Field Action issues.
• When assigned, support design verification and validation activities, including protocol development, execution, and report generation. 
• Review change notices (CNs) & Protocols/Protocol Results/RFDs for product-related changes. 

Risk Management:

• Conduct post-market risk assessments in accordance with ISO 14971 and other relevant standards.
• Update risk management files based on real-world evidence and product performance data.

Audits and Inspections:

• Perform periodic audits of projects against SOP’s and process. 
• Support internal and external audits, including preparation, participation, and follow-up activities.
• Provide subject matter expertise for HHEs and Field Actions along with the associated governing processes during regulatory inspections and customer audits.

Work special projects as assigned

Minimum Requirements

• Bachelor’s degree in engineering, science, or other related field is required.
• Minimum of seven (7) years of related experience within the medical device industry or other highly regulated field (biotech, pharma, etc.).
• Proven experience in health hazard evaluations, field action planning, CAPA, and risk management.
• In-depth knowledge of medical device regulations and standards, including FDA QSR, ISO 13485, ISO 14971, EU MDR, and related post-market requirements.
• Strong analytical skills with the ability to interpret and act on data from multiple sources.
• Excellent communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and regulatory bodies.
• Certifications such as CQE, CQA, SSGB, or RAC are a plus.

Required Knowledge, Skills and Abilities

• Strong analytical and problem-solving skills.
• Strong technical writing and presentation skills.
• Excellent communication and interpersonal skills.
• Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA).
• Project management and leadership experience is desirable. 
• Ability to work effectively in a cross-functional team environment.
• Ability to review and understand technical standards and their requirements for products.
• Knowledge of Microsoft Office Products such as Word, Excel, PowerPoint, or equivalent software applications.

The base salary for the position is a minimum of $ 100,000 and a maximum of $125,000 plus 10% annual bonus

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.