QC Technician II: Medical Device Quality & Release

Getinge; Wayne (NJ); On-site; USD 37,000 - 40,000; Full time

Benefits offered by this job

Health, Dental, Vision insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Short and Long Term Disability

FSA / Commuter Benefits

Parental and Caregiver Leave

Tuition Reimbursement

Job summary

Getinge USA is seeking a Quality Control Technician II to perform acceptance testing and inspections on in-process and finished goods, ensuring compliance with established requirements and quality systems in a regulated manufacturing setting.

The role requires documenting results, supporting SPC monitoring, and acting as a final checkpoint for product release to ensure patient safety. Training others and prioritizing daily workload are expected responsibilities.

Qualifications

• 2+ years in quality or regulated environment, or a science degree.
• Experience in FDA-regulated environments preferred.
• Ability to work 1st shift 8AM-4:30PM; overtime available.

Responsibilities

• Perform functional acceptance testing and inspections on products on the manufacturing floor.
• Review shop floor paperwork for completeness prior to release.
• Document test results and quality records accurately and timely.
• Train Inspectors on testing methods and updated policies.
• Escalate trends or risks to Quality Management for proactive action.
• Serve as final quality control checkpoint for patient-safety-related releases.

Skills

Quality control

Inspection

SPC data analysis

Documentation

Microsoft Office

Education

High School Diploma

Science-related degree preferred

Tools

SAP

Instron testing

Job description

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 Quality Control Technician II performs acceptance testing and inspection activities on in-process and finished goods to ensure products meet established requirements. This roleis responsible forexecuting testing and inspection tasks accurately, documenting resultsin a timely manner, and supporting quality system compliance in a regulated manufacturing environment.

Job Responsibilities and Essential Duties

• Perform functional acceptance testing, and inspections on products assembled on the manufacturing floor in accordance with approved procedures and test methods


• Conduct independent review of Shop Floor Paperwork (SFP) to verify completeness and accuracy prior to product release or further processing.


• Identifyand subject non-conforming materials to the NCMR processin accordance withestablished quality procedures.


• Accurately document test results, inspections, and related quality records.


• Read,comprehend, and follow job instructions, procedures, protocols, and work-related documents, including verbal and written directions.


• Train Inspectors on acceptance testing methods, applicable procedures, and newly implemented policies, as assigned.


• Assess daily priorities and adjustownwork schedule as needed to support operational requirements.


• Participate in team meetings and quality-related discussions as required.


• Serve as the final quality control checkpoint for finished products, exercising accountability for release decisions to ensure patient safety.


• Apply critical thinking, logical reasoning, and strong attention to detail when evaluating product acceptability and quality record completeness.


• Collect, record, and maintain data required for Statistical Process Control (SPC) monitoring.


• Perform routine SPC data trending to identify shifts, patterns, or early indicators of process instability.


• Escalate emerging trends, anomalies, or risks to Quality Management to support proactive decision-making.


• Develop an understanding of the full production workflow-from raw materials through final assembly-to improve judgment during final release.


• Support the transition toward a proactive Quality Control environment by identifying opportunities to prevent defects rather than react to them.


• Performadditionalduties as assigned; responsibilities listed are not exhaustive.

Minimum Requirements

• High school diploma or equivalent required;associate or bachelor'sdegree in science, Math, Business, ora relatedfield preferred.


• 2+ years of experience in a quality function or regulated environment, or a bachelor's degree, or Certified Quality Technician (CQT) certification.


• Experiencein an FDA-regulated environment preferred; medical device experience strongly preferred.


• Ability to work 1st shift Monday - Friday 8AM - 4:30PM


• Ability to work overtime preferred, but not required

Required Knowledge, Skills and Abilities

• Ability to perform functional testing, inspections, and basic measurements accurately.


• Prior Instron testing experience or prior training in one of the following Instron operator courses-Series IX, Merlin, or Blue Hill-is preferred.


• Competence in reviewing documentation for completeness and compliance.


• Ability to perform basic math across multiple units of measure.


• Ability to use electronic quality systems and databases (e.g., SAP) for data entry and record maintenance.


• Strong attention to detail and commitment to data integrity.


• Effective verbal and written communication skills.


• Ability to work collaboratively in a team environment.


• Demonstrated flexibility and willingness to learn new tasks and procedures.


• Ability to work independently, manage multiple priorities, and adapt to changing workflows.


• Proficiency with Microsoft Office Products or equivalent software applications.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices areexhibitedin decisions


• Use of computer and telephone equipment and other related office accessories/devices to complete assignments


• May work extended hours during peak business cycles


• Ability tolift upto 40 pounds occasionally and handle materials, test fixtures, and equipment.


• Must be able to perform repetitive motions, including frequent use of hands, wrists, and fingers for sample preparation, testing, and instrument operation.


• Must be able to remain in a stationary or standing position for extended periods during testing.


• Close visual acuityrequiredfor sample preparation, reading measurements, and data verification.


• Must follow all safety and environmental requirements of the QC laboratory environment.


• This role requires working in a clean room manufacturing environment that involves wearing full gowning/Personal Protective Equipment (PPE).

Pay range: $27 - $29 / hour and is eligilbe for our Excellence Incentive Plan (EIP), an annual incentive program that rewards performance against financial and operational goals.

#LI-BS1

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.