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 plus
2+ 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 experience
ERP 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

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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 agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

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Job details

Operating Company:

Nobel Biocare

Location:

United States of America, California, Yorba Linda

Date Posted:

2026-07-06

Req Number:

R5026521

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Cleanliness and Contamination Control Manager

Caring for our employees and their families

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