Quality Assurance Manager in Santa Ana, California at Ajulia Executive Search
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Job Description
- Location: Santa Ana, California
- Type: Direct Hire
- Job #26294
Are you looking to lead enterprise-wide quality assurance initiatives within a highly regulated industrial and cleanroom services environment? This Quality Assurance Manager opportunity focuses on overseeing Quality Management Systems (QMS), ISO compliance, audit readiness, and continuous improvement initiatives across multiple operational facilities nationwide. This role is ideal for an experienced quality leader with expertise in regulated manufacturing, cleanroom operations, or aseptic environments who thrives in fast-paced operational settings and is passionate about driving compliance, process improvement, and quality excellence across multi-site operations.
Responsibilities:
- Lead execution, implementation, maintenance, and continuous improvement of enterprise Quality Management Systems (QMS) across multiple ISO-certified facilities
- Ensure compliance with ISO standards, internal quality procedures, customer specifications, and regulatory requirements across operational sites
- Oversee quality assurance initiatives supporting cleanroom, aseptic, sterile, and controlled-environment service operations
- Serve as primary quality representative during internal audits, ISO certification audits, customer audits, and compliance reviews
- Analyze quality metrics, performance trends, risks, and nonconformance data to implement corrective and preventive actions (CAPA)
- Develop, update, and standardize quality assurance programs, SOPs, policies, and operational quality procedures
- Partner cross-functionally with Operations, Engineering, Production, and Leadership teams to drive continuous improvement initiatives
- Lead and mentor Quality Assurance personnel and site-level quality leadership teams across multiple locations
- Support supplier and vendor quality initiatives to ensure adherence to quality standards and operational expectations
- Monitor audit findings, corrective action plans, and compliance documentation to ensure timely resolution and continuous audit readiness
- Conduct training, coaching, and quality leadership activities across operational facilities nationwide
- Travel to operational facilities to provide onsite quality oversight, audit support, and process improvement leadership
Required Experience:
- Bachelors degree in Biology, Chemistry, Microbiology, Engineering, Life Sciences, or related field required
- 10+ years of Quality Assurance experience within regulated manufacturing, cleanroom operations, pharmaceutical, biotechnology, medical device, or controlled-environment industries required
- Strong experience leading ISO-certified Quality Management Systems (QMS) within multi-site operational environments required
- Experience supporting aseptic, sterile, cleanroom, or contamination-controlled operational environments required
- Strong experience leading internal audits, ISO certification audits, customer audits, and compliance initiatives required
- Experience developing and implementing CAPA programs, quality metrics, SOPs, and continuous improvement initiatives
- Strong understanding of regulatory compliance, quality systems, root cause analysis, and audit readiness procedures
- Excellent leadership, communication, organizational, and problem-solving skills
- Ability to manage enterprise-wide quality initiatives across multiple operational facilities
- Strong experience collaborating cross-functionally with operations, engineering, and leadership teams
- Ability and willingness to travel approximately 30% nationwide required
Preferred Experience:
- Experience within industrial laundry, cleanroom garment processing, or textile service operations preferred
- Experience supporting pharmaceutical, biotechnology, or medical device manufacturing environments preferred
- ASQ certifications such as CQE, CQA, or related quality certifications preferred
- Experience leading enterprise-wide quality initiatives across nationwide operations preferred
- Experience supporting supplier quality, vendor compliance, and operational standardization initiatives preferred
- Strong background in continuous improvement, Lean, or Six Sigma methodologies preferred
Benefits:
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- Paid Time Off
- 401(K) with company match
- Professional development opportunities
- Nationwide leadership exposure
Salary: $120K-$160K
Ask for: Brenna
Job Id: 26294
Ajulia Executive Search is a New Jersey based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements.
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