QC Technician II - Wayne, NJ

QC Technician II - Wayne, NJ

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Maquet Cardiovascular LLC 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.

The Quality Control Technician II performs acceptance testing and inspection activities on in-process and finished goods to ensure products meet established requirements. This role is responsible for executing testing and inspection tasks accurately, documenting results in a timely manner, and supporting quality system compliance in a regulated manufacturing environment. This role requires working in a clean room manufacturing environment that involves wearing full gowning/Personal Protective Equipment (PPE).

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.
• Identify and subject non-conforming materials to the NCMR process in accordance with established 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 adjust own work 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.
• Perform additional duties as assigned; responsibilities listed are not exhaustive.

Minimum Requirements:

• High school diploma or equivalent required; associate or bachelor's degree in science, Math, Business, or a related field preferred.
• Minimum of 2 years of experience in a quality function or regulated environment, or a bachelor's degree or Certified Quality Technician (CQT) certification.
• Experience in an FDA-regulated environment preferred; medical device experience strongly preferred.

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:

• Demonstrates environmental awareness and adherence to safe work practices, and complies with all environmental, health, and safety requirements of the Quality Control laboratory environment.
• Work may be performed in an ISO Class 7 cleanroom requiring full head-to-toe gowning; up to 8 hours per day, based on daily operational needs.
• Ability to lift up to 40 pounds occasionally and handle materials, test fixtures, and equipment.
• Maintains a stationary or standing position for extended periods during testing activities.
• Utilizes computer and telephone equipment and other standard office tools to complete assignments.
• Ability to lift up to 40 pounds occasionally and handle materials, test fixtures, and equipment.
• Performs repetitive tasks, including frequent use of hands, wrists, and fingers for sample preparation, testing, and instrument operation.
• Requires close visual acuity for sample preparation, measurement, and data verification.
• May work extended hours during peak business periods.

Salary range: $27/hr - $29/hr plus overtime

About us:

With a firm belief that every person and community should have access to the best possible care, Maquet Cardiovascular LLC 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. Maquet Cardiovascular LLC 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.