Somerville, NJ, 08876
Job description
Quality Assurance Technician
Somerville, NJ
Competitive Pay and Benefits
Shifts: 1st & 2nd
The role of a Quality Assurance Technician is pivotal in supporting quality assurance functions within a medical device sterilization setting. The individual in this position will be accountable for ensuring that sterilization processes adhere to verified parameters, regulatory standards, customer demands, and internal quality protocols. Key responsibilities include reviewing sterilization documentation, monitoring process controls, facilitating product release activities, and ensuring compliance with FDA standards, current Good Manufacturing Practices (cGMP), and relevant ISO guidelines. The ideal candidate will exhibit meticulous attention to detail, superb documentation capabilities, and the ability to thrive in a regulated manufacturing atmosphere.
Key Responsibilities
- Examine sterilization cycle documentation to ensure adherence to validated process parameters and prescribed procedures.
- Conduct thorough reviews of load documentation and associated quality records.
- Confirm the accuracy and completeness of documentation prior to product approval for release.
- Assist in the quality review and endorsement of sterilized products as per internal protocols and customer stipulations.
- Validate essential sterilization process parameters such as temperature, humidity, gas concentration, and dosage levels.
- Carry out pre-cycle and post-cycle software verification tasks.
- Act as an independent process verifier and observer during sterilization procedures as needed.
- Support environmental monitoring endeavors and quality enhancement initiatives.
- Ensure adherence to current Good Manufacturing Practices (cGMP) and ALCOA principles of data integrity.
- Investigate, record, and escalate instances of abnormal equipment behavior, system alerts, or quality issues.
- Identify and address concerns that might affect product sterility assurance or regulatory compliance.
- Assist with internal audits, customer evaluations, and regulatory inspections.
- Maintain productivity levels and uphold quality performance while actively participating in continuous improvement efforts.
- Abide by all safety protocols, quality guidelines, and organizational policies.
- Execute additional duties and projects as assigned.
Qualifications
- Associate’s degree or higher in a scientific, quality-related, or technical field, or equivalent experience.
- 2-5 years of experience in quality assurance within a GMP-regulated environment, ideally in medical device manufacturing or sterilization services.
- Familiarity with sterilization methods and pertinent industry standards.
- Knowledge of sterility assurance principles and quality management systems.
- Understanding of FDA regulations, cGMP practices, and ISO standards, such as ISO 11135, ISO 11137, and ISO 13485.
- Impeccable attention to detail with an ability to analyze and interpret technical documentation.
- Strong organizational skills capable of handling multiple priorities simultaneously.
- Robust analytical, problem-solving, and decision-making capabilities.
- Excellent written and verbal communication skills.
- Able to work independently, while also collaborating efficiently with cross-functional teams.
- Strong dedication to quality, compliance, and operational excellence.
- Reliable, punctual, and possessing a positive attitude and a strong work ethic.
- Must be authorized to work in the United States.
STEMHUNTER is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, and gender expression), national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. We comply with all applicable equal employment opportunity and affirmative action regulations.
