Cleanliness and Contamination Control Manager

Job Description:

The Cleanliness and Contamination Control Manager is responsible for ensuring cleanliness control and contamination control at the manufacturing site.

The Cleanliness and Contamination Control Manager is responsible to:

• 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:

Required:

• Bachelor’s degree in in a relevant scientific discipline (preferably in microbiology)
• 2+ years of experience in the field of contamination control in the medical device or pharmaceutical industry
• Must reside within a commutable distance to Yorba Linda, CA.

Critical Skills/technical know-how:

• ISO 13485 (Quality Management System for Medical Devices)
• Sterilization (ISO 11137-1&2)
• Analytical Methods (ISO 11737-1,2,3)
• Clean room & Utilities (ISO 14644, ISO 14698, ISO 8573 series)
• ISO 10993-1
• Solid knowledge of regulatory requirements related to contamination control and cleanliness control or ability to rapidly develop expertise to function independently with minimal supervision.
• Solid expertise in statistical data analysis
• 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
• Sound SAP system understanding
• Project managements, multilayered project management, networking
• Beneficial comprehensive experience of manufacturing process needs to meet cleanliness requirements
• Experience in working in a highly ambiguous matrix organization

Critical Success Factors / Key Challenges:

• Able to drive improvement projects simultaneously
• Able to implement clear procedures, that describe process adequately and are regulatory compliant as well as efficient use of resources
• Able to assess the impact of manufacturing changes (e.g equipment, process, material and environmental changes) on contamination and cleanliness control
• Author, revise, and review technical and procedural documentation related to contamination and cleanliness control practices

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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.

$80,000 - $120,000

Operating Company:

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. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

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.