Sr. Quality Process Engineer

BIOLASE, Inc. is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine. BIOLASE's products are focused on better enabling clinicians to repair and restore patient's dental conditions while reducing the pain, fear, and anxiety generally associated with dentistry. BIOLASE is committed to elevating the standard of care in dentistry, while enabling clinicians to achieve better business returns.

Job Description

We are currently seeking a  Sr. Quality Process Engineer to be based in Corona, CA to support the company’s quality engineering, production and R&D systems as assigned. 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Handle supplier quality: resolve issues, perform quality system and technical/process and corrective/preventative actions.
• Champion Continuous Improvement Initiatives and Root Cause/CAPA programs.
• Implement, Sustain, and support all Process and Process Engineering activities.
• Lead for weekly MRB meetings line-disposition activities (NCR, SCAR, etc)
• Provide and prioritize QA/QC support for production, purchasing, engineering and customer service departments as needed.
• Responsible for ensuring the training of employees on FDA QSRs and ISO regulations.
• Responsible for ensuring that equipment/calibration and preventative maintenance programs are Maintained.
• Support internal and external quality system audits.
• Host product safety and compliance inspections, including all required follow up.
• Complete other duties, tasks and projects as assigned.

SUPERVISORY RESPONSIBILITIES 

This job has no direct supervisory responsibilities.

Skills & Experience

QUALIFICATIONS 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE 

Bachelor’s Degree (BA) in Engineering or Quality, from four-year college or university and 10-15 years related experience and/or training; or equivalent combination of education and experience. 

LANGUAGE SKILLS 

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

MATHEMATICAL SKILLS 

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 

REASONING ABILITY 

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

CERTIFICATES, LICENSES, REGISTRATIONS

Certified Quality Management and/or Certified Quality Engineer preferred.

PHYSICAL DEMANDS 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally required to sit, climb or balance; stoop, kneel, crouch, or crawl. The employee will regularly be required to stand, walk, use hands to finger, handle or feel; reach with hands and arms; talk or hear. The employee must regularly lift and/or move up to 25, and occasionally, up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, risk of electrical shock, and risk of radiation. The noise level in the work environment is usually moderate. Standard light manufacturing and office environment.

ADDITIONAL INFORMATION

Five years minimum experience in Quality Engineering with medical devices.

Ability to effectively communicate verbally and in writing and interface with other departments on a daily basis. Self motivated, assertive individual who is detail oriented and results driven.

BIOLASE is an EOE including disability/veteran