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Cleanliness and Contamination Control Manager
Job in
Yorba Linda, Orange County, California, 92686, USA
Listed on 2026-08-08
Listing for:
Envista
Full Time
position Listed on 2026-08-08
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
5026521
United States of America Quality and Regulatory Affairs Job description
The Cleanliness and Contamination Control Manager is an individual contributor and responsible for ensuring cleanliness and contamination control at the manufacturing site.
Responsibilities:
Define and maintain contamination control and cleanliness control strategies.
Drive improvements to enhance cleanliness control, including cleanroom setup, product final cleaning, tool cleaning, hygiene, and rules of conduct.
Create/update procedures for cleanliness and contamination control and ensure they are adhered to.
Ensure compliance with Quality Regulations, ISO, AAMI standards, and regional requirements.
Lead investigations of monitoring excursions, contamination incidents, and deviations from contamination and cleanliness control procedures.
Ensure monitoring related contamination and cleanliness control is performed.
Analyze and interpret contamination control and cleanliness monitoring data, identifying trends and implementing corrective actions.
Act as a Cleanliness and Contamination Control Subject Matter Expert (SME) during routine operations and audits.
Job requirements
QUALIFICATIONS:
Bachelor’s degree in a relevant scientific discipline;
Microbiology or Biology is a plus2+ years of experience in the field of contamination control; medical device or pharmaceutical experience is required
Solid knowledge of regulatory requirements related to contamination control and cleanliness control or ability to rapidly develop expertise to function independently with minimal supervision.
ISO 13485 experience (QMS for pharma or medical device)
ISO 11137 - 1&2 sterilization experience (Gamma irradiation)
ISO 14644, ISO 14698, ISO 8573 series experience required (Clean room & utilities)
ISO 10993-1 required (standard for evaluating the biological safety of medical devices within a risk management process)
Solid expertise in statistical data analysis
Project management experienceERP experience; SAP is a plus PREFERRED:
Analytical Methods preferred (ISO 11737-1,2,3)
Comprehensive experience of manufacturing process needs to meet cleanliness requirements is a plus Experience in working in a highly ambiguous matrix organization is a plus
Good interpersonal skills with ability to work effectively with other groups
Excellent verbal & written communication skills
Strong interpersonal skills with a high level of accurateness, integrity, commitment, ethics and proactivity to cultivate a network of productive relationships in an international matrix environment
Strong organizational and multitasking skills with the ability to prioritize tasks independently to meet the objectives of multiple projects simultaneously
Strong analytical skills and result orientation
Analyzes issues and breaks them down. Makes documented, systematic and rational judgments based on relevant information
Fluency in English and the local language is mandatory, other languages are welcome#LI-RJ1
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Target Market Salary Range:
Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.
At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.$86,100.00 - $ Annual Operating Company:
Nobel Biocare Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing…
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