QC Technician III - Wayne, NJ

Getinge•Wayne, NJ

1d•$27 - $29•Hybrid

About The Position

The Quality Control Technician III performs advanced testing activities on in-process and finished products, ensuring accuracy, compliance, and timely completion of test requirements. This role serves as a technical expert within QC, providing guidance, troubleshooting support, and feedback to Engineering and cross-functional teams. Supports validation activities, assists in enhancing testing methods, mentors QC staff, and plays a key role in identifying and resolving quality issues to maintain product integrity and patient safety.

Requirements

High School Diploma or equivalent required.
Minimum 3 years of experience in quality functions within a regulated environment; FDA-regulated medical device experience ideal.
Prior experience with Instron platforms (Blue Hill) preferred.
Strong understanding of testing principles, quality systems, and regulated manufacturing environments.
Ability to read and interpret SOPs, protocols, engineering drawings, and specifications.
Demonstrated ability to identify issues, conduct basic root-cause analysis, and propose effective solutions.
Ability to mentor others and provide technical leadership without direct supervisory authority.
Strong verbal and written communication skills.
Prior Instron testing experience or prior training in one of the following Instron operator courses (Series IX, Merlin, or Blue Hill) required.
Ability to use electronic quality systems and databases (e.g., SAP) for data entry and record maintenance.
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.
High attention to detail and strong organizational skills.

Nice To Haves

Associate’s or Bachelor’s degree in Science, Math, Engineering, or related field preferred.
ASQ certifications (CQT, CQI, CQA) strongly preferred.

Responsibilities

Perform destructive and non-destructive testing on in-process and finished goods (e.g., Visual Inspection, Seal Width, Length, Water Entry Pressure, Instron Testing, Radial Burst, Borescope, Spectrophotometry).
Execute testing for Engineering Studies, Validations, and Product Development activities.
Assess test priorities independently and adjust workload to meet deadlines and production needs.
Ensure all testing is performed according to established procedures, protocols, quality standards, and regulatory requirements.
Provide technical feedback to Engineering on product performance, testing outcomes, process improvements, and equipment behavior.
Troubleshoot testing issues, equipment failures, data anomalies, and material inconsistencies; escalate findings appropriately.
Train QC technicians on test methods, procedures, updated policies, and new equipment.
Serve as a subject matter expert for specific testing platforms, including Instron, or specialized QC instrumentation.
Provide ongoing guidance to junior technicians to ensure compliance, proper technique, and consistent testing execution.
Generate accurate documentation, test results, data sheets, and quality records in compliance with regulatory and internal requirements.
Create, review, or provide feedback on NCMRs for nonconforming materials.
Assist in drafting or redlining test procedures, work instructions, inspection plans, and lab documentation as requested.
Generate Certificates of Conformance for international shipments.
Recommend enhancements to test methods, fixtures, workflows, and equipment based on observations and data.
Perform product release testing when necessary.
Perform data entry, file records, maintain lab organization, and follow good documentation practices.
Act as the final approval authority for finished product release and ensure adherence to all quality, safety, and regulatory requirements on behalf of the organization.
Demonstrate advanced critical thinking and analytical judgment in evaluating test results, supporting documentation, and readiness for release.
Lead the collection, validation, and analysis of Statistical Process Control (SPC) data across multiple production lines or product families.
Conduct in‑depth SPC trending, process capability assessments (e.g., Cp/Cpk), and early detection of potential nonconformities.
Provide regular feedback to manufacturing, engineering, and quality leadership regarding process stability, trends, and risks.
Mentor QC Technicians I and II in understanding upstream/downstream impacts, the full production process, and holistic product flow.
Drive proactive quality initiatives by identifying systemic issues, proposing preventive actions, and collaborating on continuous improvement activities.
Serve as a subject matter resource during investigations, change control reviews, and process improvements.
Support cross‑functional alignment to ensure the QC function consistently anticipates risks rather than reacting to them.