Quality Engineer - Complaints

SaniSure; Camarillo (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

SaniSure, located in Camarillo, CA, seeks a Quality Engineer with extensive experience in the biotechnology sector. This role involves driving quality across manufacturing processes, leading investigations, and supporting regulatory compliance. The successful candidate will ensure product quality through rigorous evaluations and process enhancements.

Additional responsibilities include implementing CAPAs, conducting risk assessments, and engaging with teams for continuous improvement. A Bachelor's degree in a relevant field and over 5 years of experience is required.

Qualifications

• 5+ years of experience in quality operations within relevant industries.
• Experience in GMP or cleanroom environments.
• Strong skills in CAPA, change control, and validation.

Responsibilities

• Lead quality investigations and implement corrective actions.
• Conduct risk assessments and ensure closure of quality events.
• Collaborate with teams to improve processes and quality.

Skills

Quality systems management

Continuous improvement methodologies

Cross-functional teamwork

Technical writing

Problem-solving

Education

Bachelor’s degree in Engineering or related field

Tools

Microsoft Office

Job description

About SaniSure

SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today’s most innovative and life-changing medicines.

Job Summary

The Quality Engineer works closely with Operations, Manufacturing Engineering, R&D, Supply Chain, and Quality teams to drive quality performance across the manufacturing of single-use bioprocessing components, tubing, molded components, and single-use assemblies used in biopharmaceutical manufacturing. The Quality Engineer will lead quality investigations, drive process improvements, support GMP manufacturing quality systems, and serve as the primary quality contact for manufacturing nonconformances, customer complaints, and in-market product issues. The Quality Engineer is responsible for root cause analysis, CAPA implementation, and continuous improvement initiatives to ensure product quality, sterility assurance, and regulatory compliance.

Essential Functions

• Lead quality investigations related to customer complaints, in-market defects, sterility concerns, particulate issues, and product nonconformances, including root cause analysis and implementation of corrective and preventive actions (CAPA).
• Conduct impact and risk assessments related to product quality issues and ensure timely closure of quality events in accordance with Quality Management System requirements.
• Collaborate with Manufacturing, Engineering, R&D, Supply Chain, and Regulatory teams to investigate failure modes, implement corrective actions, and support product and process changes through change control processes.
• Interface with biopharma customers and suppliers to address product or manufacturing nonconformances and support customer audits, supplier audits, and regulatory inspections.
• Lead process improvement initiatives utilizing Statistical Process Control (SPC), Six Sigma, Lean Manufacturing tools, 5S, Value Stream Mapping, Control Plans, PFMEA, and Process Mapping to improve manufacturing processes and product quality.
• Improve and support manufacturing processes related to cleanroom assembly, tubing extrusion, injection molding, packaging and sealing, sterile barrier systems, and lot traceability to ensure consistent product quality and sterility assurance.
• Lead Manufacturing Quality Assurance initiatives to ensure process flows are effective, controlled, and compliant with internal quality systems, GMP expectations, ISO standards, and customer requirements.
• Provide guidance to manufacturing and quality teams on root cause and corrective action activities and recommend process improvements to ensure consistent implementation of internal requirements and external regulations and standards.
• Monitor process performance metrics and quality trends and provide status reporting regarding manufacturing processes, deliverables, risks, and improvement initiatives to management.
• Advise manufacturing and quality teams on the implementation of international standards and Good Documentation Practices (GDP) as they relate to manufacturing and quality system requirements.
• Participate in investigations and dispositions of product nonconformances, change controls, corrective action requests (CARs), and Material Review Board (MRB) activities.
• Generate and maintain procedures, work instructions, forms, and quality system documentation to ensure standardization of practices across the organization.
• Implement required changes to existing training programs and assist in training staff members on quality procedures, process changes, and documentation practices.
• Support validation activities, risk management activities, and continuous improvement initiatives related to manufacturing processes and product quality.
• Perform other duties as assigned.

Education

• Bachelor’s degree in Engineering, Biological Sciences, Bioprocess Engineering, Chemistry, or related technical field.

Required Experience & Competencies

• 5+ years of experience in quality operations within biotechnology, pharmaceutical, medical device, or single-use technology manufacturing.
• Experience working in GMP or cleanroom manufacturing environments.
• Strong experience with quality systems including CAPA, change control, nonconformance management, document control, product release, validation, and risk management.
• Strong understanding of ISO 9001 and/or ISO 13485 and applicable regulatory standards such as 21 CFR Parts 210, 211, and/or Part 820.
• Experience driving continuous improvement through Six Sigma, Lean Manufacturing, SPC, PFMEA, or similar methodologies.
• Experience supporting manufacturing processes such as extrusion, molding, cleanroom assembly, packaging, sterilization, or related manufacturing processes.
• Ability to lead cross‑functional projects across multiple sites, suppliers, and customers globally.
• Strong technical writing, documentation, communication, and problem‑solving skills.
• Proficiency in Microsoft Office applications.
• Ability to work effectively and efficiently in a team environment and lead change across multiple departments.

Equal Employment Opportunity Policy

We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender identity or expression, sexual orientation, national origin, citizenship status, uniform service member status, pregnancy, age (40 and over), genetic information, disability (mental and physical), or any other protected status in accordance with all applicable federal, state, and local laws.