Quality Engineer (Biotech)

Company: VMRD, Inc.

Location: Fullerton, CA

Job Title: Quality Engineer

Type: Exempt/FT

Department: Manufacturing-Fullerton

Job Summary

The Quality Engineer is responsible for ensuring product and process quality through inspection, testing, and troubleshooting. This individual will also provide technical support to production teams and drive continuous improvement initiatives. This role combines hands-on quality control with analytical problem-solving and cross-functional collaboration to enhance operational efficiency, reduce defective products, and support regulatory compliance initiatives.

Duties And Responsibilities

• Follows all policies, protocols, and SOPs
• Quality Control
• Analyze experimental data and interpret results to write reports and summaries of findings.
• Perform inspections of raw materials, in-process products, and finished goods.
• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
• Document and report quality issues, deviations, and non-conformances.
• Maintain accurate records of inspections, test results, and corrective actions.
• Collaborate with production and quality assurance teams to resolve quality issues.
• Support internal audits and participate in external regulatory inspections.
• Conduct continuous improvement studies and collect all necessary data for process and product improvement.
• Technical Support
• Provide remote and on-site operational technical support for diagnostic devices.
• Assist with customer complaints and investigations.
• Maintain detailed records of support cases, and resolutions.
• Support products by preparing documentation and training materials.
• Assist with product development based on customer experience and technical challenges.
• Conduct research, or assist in the conduct of research, including the collection of information and samples.
• Monitor and observe experiments, record production and test data for evaluation by company personnel.
• Keep detailed logs of all work-related activities.
• Process Improvement
• Analyze microbiology lab workflows, testing protocols, and operational data to identify areas of improvement.
• Collaborate with lab personnel, quality teams, and management to streamline sample handling, testing, and reporting procedures.
• Monitor key performance indicators (KPI's) and establish benchmarks for lab efficiency and quality.
• Document process changes and update SOP's to reflect new procedures.
• Support training and change management efforts to ensure successful adoption of improvements.
• Ensure all process changes comply with all applicable regulations (FDA, ISO13485:2016, CLIA, GMP, etc.)
• Other duties as assigned.
  

Required Knowledge, Skills And Abilities

• Mutual respect and regard for others
• Excellent organizational skills
• Ability to multi-task and prioritize effectively in a fast-paced environment
• Good information technology skills (MS Office and laboratory software)
• Accuracy, thoroughness, and attention to detail
• Proven ability to collaborate with peers
• Customer focused mindset with a commitment to service excellence
• Analytical thinking and problem-solving abilities
• Effective communication and documentation skills
  
  

Desired Qualifications And Experiences

• 3+ years' experience in technical support, R&D, or Quality Control
• Regulatory experience with ISO:13485:2016, ISO:9001:2015 and IVDR:2017 preferred.
  
  

Education, Licenses And Certifications

• Mandatory B.S. degree in Microbiology, Biomedical Engineering, or a related field. (Master's degree or PhD preferred)
  
  

Physical Requirements For The Job

• Requires standing/walking in a Manufacturing/Warehouse/Office environments
• Frequent use of computers, diagnostic equipment, and remote support tools
• Utilizes PPE when working in clinical or laboratory settings
  
  

Pay Range Data

• The pay range for this position is $79,100 -$91,700 annually. We are open to reviewing additional candidates with more or less experience and the pay range may differ if filled at a different level. Our pay ranges are determined by job responsibility and regional benchmarks. The wage listed is just one component of VMRD's total compensation package for employees.
  
  

Full-Time Benefits

• Paid Vacation: Accrued monthly; Starting at 8hrs/month or 12 days per year based on length of service
• Paid Holidays: 8 regular holidays
• Paid Sick Leave for illness or qualified event in accordance with WA Paid Sick Leave
• Health insurance: Medical, Dental, Rx & Vision; Paid 80% of premium for employee & family
• HealthiestYou Teladoc with access to free medical and mental health services
• Health Savings Account with employer contributions
• Paid Air Ambulance Membership
• 401k: A 100% match of employee contribution up to 6% of salary
• Paid Life Insurance Policy, AD&D and LTD
  
  

Background Check, Education Verification, Work Authorization

Salary: $79100 - $91700 per year

Job Posted by ApplicantPro