Description
\t\t\t\t\t•\tLead quality investigations related to in-the-market defects to identify root cause and implement corrective actions and preventative actions.•\tCollaborate with cross-functional teams to investigate failure modes and execute impact assessments to ensure appropriate countermeasures are developed and launched.•\tInterface with customers and suppliers to address non-conformances identified during manufacturing.•\tLead process improvement initiatives utilizing Statistical Process Control (SPC) and Six Sigma methodology such as 5S, Value Stream Mapping, Control Plans, PFEMA, and Process Mapping.•\tLead Manufacturing Quality Assurance aspects of process control, initiating projects to ensure that targeted process flows are effective and achieves operational requirements, and provide guidance to SME’s on root cause and corrective action (RCCA) activities.•\tRecommend process improvements to management and execute to ensure consistent implementation of internal requirements and external regulations and standards.•\tProvide status reporting regarding manufacturing processes deliverable, dependencies, risks and issues, communicating across teams and management.•\tAdvise manufacturing and quality teams on the implementation of international standards (ISO 9001, regulatory standards, etc.) as they relate to manufacturing of product and Good Documentation Practices (GDP).•\tParticipate in the investigations and dispositions of product, non-conformances and changes, CARs and MRB.•\tGenerate and maintain procedures, work instructions and forms, as necessary to ensure standardization of practices across SaniSure.•\tImplement required changes to existing training programs and assist in training staff members.•\tPerform other tasks as assigned.
\t\t\t\t\t\t\t\t\t\tSkills
\t\t\t\t\tQuality engineering, Quality assurance, iso 13485, technical documentation, asq certified, asq certification, asq, capa, complaints, change control, root cause analysis, medical device, pharmaceutical, biotechnology, biotech, 21 CFR
\t\t\t\t\t\t\t\t\t\tTop Skills Details
\t\t\t\t\tQuality engineering,Quality assurance,iso 13485,technical documentation,asq certified,asq certification,asq,capa,complaints,change control,root cause analysis,medical device,pharmaceutical,biotechnology,biotech,21 CFR
\t\t\t\t\t\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\t•\tBachelor’s degree in Business, Sciences or Engineering•\t5+ years of experience in quality operations within a biotechnology or pharmaceutical manufacturing facility.•\t5+ years of experience with technical documentation for complex activities in the areas of the Quality System that includes corrective actions, change control, quality audits and validation of manufacturing processes, or product development in a pharmaceutical or medical device environment.•\tStrong understanding of global pharmaceutical and biotechnology product regulations with ISO 9001 and/or 13485:2003 and 21 CFR Parts 210 and 211 and/or Part 820.•\tAble to drive continuous improvement through collaboration and consensus building.•\tProficient problem-solving skills using continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent.•\tDemonstrated proficiency in multiple quality systems including exception management, change control, document control, product release, etc. with strong decision-making skills utilizing risk management.•\tQuality System Knowledge (e.g. ISO 9001, ISO 13485).•\tAdvanced skills with MS Office software are preferred.•\tAble to lead change environment across multiple sites and customers globally.•\tAble to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors, contractors, and customers.
\t\t\t\t\t\t\t\t\t\tExperience Level
\t\t\t\t\tIntermediate Level
\t\t\t\t\tJob Type & LocationThis is a Permanent position based out of Camarillo, CA.
Pay and BenefitsThe pay range for this position is $90000.00 - $110000.00/yr.
Medical, dental, 401k, sick pay, pto,
Workplace TypeThis is a fully onsite position in Camarillo,CA.
Application DeadlineThis position is anticipated to close on Feb 27, 2026.
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