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Sr. Quality Engineer, Quality Operations - Wayne, NJ
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Sr. Quality Engineer, Quality Operations - Wayne, NJ

Getinge -
Wayne, NJ

Apply Now

Job Details

Full-time
$115,000 - $120,000 a year

Benefits

Commuter assistance
Caregiver leave
Disability insurance
Health insurance
Dental insurance
Flexible spending account
Tuition reimbursement
Paid time off
Parental leave
Vision insurance
401(k) matching
Life insurance

Qualifications

Accreditation standards (regulatory compliance area)
ISO standards
Bachelor's degree
Medical device manufacturing facility experience
Pharmaceutical company experience
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Productivity software
Quality audits
Manufacturing
Root cause analysis
Cross-functional collaboration
Project leadership
Cross-functional communication
FDA regulations

Full Job Description

Sr. Quality Engineer, Quality Operations - 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

As a Sr. Quality Engineer specializing in Quality Operations, you will be responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.

Job Responsibilities and Essential Duties

Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement.
Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations.
Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
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.
Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy.
Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity.
Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction.
Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
Provide mentorship and guidance to new Engineers/Interns within the organization.

Minimum Requirements

Bachelor’s degree in engineering, Science, or other related field is required. ASQ, CQE, Six Sigma Green Belt or other applicable certifications are a plus.
A minimum of 7 years’ experience in Quality or Engineering.
Experience in a medical device or pharmaceutical industry.
Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.

Required Knowledge, Skills, and Abilities

Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans.
Project management and leadership experience is desirable.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.
Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
Ability to work effectively in a cross-functional team environment.
Ability to review and understand technical standards and their requirements for products.
Proficiency in Microsoft Office Products such as Word, Excel, or equivalent software applications.

Salary range: $115k - $120k plus 10% annual bonus

INDLG

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.  

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Commuter Benefits
Parental and Caregiver Leave
Tuition Reimbursement

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

Pay: $115,000.00 - $120,000.00 per year

Benefits:

401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance

Work Location: In person

Apply Now

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