Tech, QA Assurance

Your Team

You will be part of a highly skilled Quality organization dedicated to maintaining the highest standards in medical device manufacturing. Our team thrives in a collaborative, fast‑paced environment where attention to detail and proactive problem solving are essential. When you join us, you will collaborate with engaged professionals who value knowledge sharing, mentorship, and continuous development—while keeping patient safety at the center of everything we do.

What We Offer From Day 1

• Medical, Dental, Disability, and Life Insurance Coverage
• Vision Plan
• Paid Vacation Days and Paid Holidays
• Paid Parental Leave
• Retirement Plan
• Employee Stock Purchase Program
• Educational Assistance Plan

What You’ll Be Doing

• Ensure compliance with Quality System Regulations related to manufacturing processes, methods, and quality functions.
• Review and approve quality documentation, including In‑Process Checker Charts, Product Retention Records, Control Charts, Mold Approvals, Batch Records, and related records.
• Conduct routine manufacturing audits of machine parameters, setups, and finished product to ensure compliance with specifications and procedures.
• Audit sampling techniques, testing skills, and documentation executed by TIQs.
• Provide immediate notification and escalation to Quality Management regarding potential quality issues or risks.
• Assist and coordinate quality and manufacturing protocols, including validation and improvement initiatives.
• Provide training on Good Documentation Practices (GDP), Statistical Process Control (SPC), Total Integrated Quality, and related quality tools.
• Support mold approval activities and mold startup evaluations, when applicable.
• Gather, analyze, audit, and interpret data using SPC tools to identify trends and recommend process improvements that reduce scrap, DPMs, complaints, and cost of non‑conformance.
• Maintain, review, audit, and calculate control chart limits as required.
• Ensure all machinery, equipment, tools, and measuring devices comply with Corporate, GMP, and regulatory requirements.
• Publish monthly Quality Indicators, including DPMs and Pareto analyses for assigned areas.
• Propose and submit improvements or modifications to specifications and Standard Operating Procedures.
• Maintain timely communication with internal and external customers/suppliers regarding quality trends, complaints, and DPM performance, as applicable.
• Assist in the development and certification of TIQs.
• Participate in and lead special projects related to assigned quality responsibility areas.
• Manually and electronically document required process and production information (e.g., checker charts, POMs) per procedures and specifications.
• Conduct EHS inspections to identify safety hazards and environmental aspects; analyze incidents and near misses and implement corrective actions.
• Support software application audit execution.
• Assist in the generation, investigation, and resolution of non‑conformances.
• Observe data privacy and confidentiality policies at all times.

What You’ll Bring:

• Bachelor’s Degree in Science or related field.
• Minimum of two (2) years of Quality experience within the Medical Device industry.
• Experience using measurement and inspection instrumentation.
• Strong analytical, auditing, and documentation skills.
• Effective interpersonal and communication skills.
• Bilingual (English & Spanish)

SHIFT: Shift C (M-F from 20:00-6:00) and/or Shift D (two weeks day 8hrs and Sat-Sun 12hrs)