Envista

Cleanliness and Contamination Control Manager

United States of America, California, Yorba Linda

Sponsorship not specified$105k-$129kDetected 15 days ago

Data AnalysisProject ManagementSAPERPRecruitingHRMedical DevicesCommunication

About the role

Job Description: The Cleanliness and Contamination Control Manager is an individual contributor and responsible for ensuring cleanliness and contamination control at the manufacturing site.
The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.
The "EEO is the Law" poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

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.
Lead investigations of monitoring excursions, contamination incidents, and deviations from contamination and cleanliness control procedures.

2+ years of experience in the field of contamination control
ISO 14644, ISO 14698, ISO 8573 series experience required (Clean room & utilities)
Solid expertise in statistical data analysis
Bachelor's degree in a relevant scientific discipline
Microbiology or Biology is a plus
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 10993-1 required (standard for evaluating the biological safety of medical devices within a risk management process)
Project management experience
ERP experience
SAP is a plus

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

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.
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.
$105,200 - $128,600

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.
Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
Nobel Biocare
Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
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.

This listing is sourced directly from Envista's careers page and normalized into a canonical job model.