Job Description:

JOB SUMMARY:

The Quality Engineer assures the quality of processes and products by performing audits, inspections, tests, defect analysis, trend analysis, programming & troubleshooting inspection equipment, calibration maintenance, and reporting on results of measurement standards. He/She assures consistent quality of suppliers and production by validating processes; providing documentation from measurement analysis, and helping departments understand the interpretation of collected data. Jobs that provide engineering technical support in this field should be assigned to this job family.

This position will be located on-site in our Yorba Linda, CA office, 5 days per week.

Job Requirements:

• Bachelor’s degree from a four-year College or University in an Engineering discipline.
• 4-6 years of experience with FDA and international medical device regulations (i.e., 21 CFR Part 820, ISO 13485, MDD, JPAL and CMDR).
• Ability to multi-task to address existing and potential QA issues routinely.
• Proficient in Microsoft Word, Excel, Power Point, etc. or equivalent applications.

PREFERRED QUALIFICATIONS:

• Compliance certifications highly preferred (i.e. ISO 13485, ISO 14791), Six Sigma Greenbelt: Process Excellence.
• Available to work on different rotations or hours depending on business demands.
• Available to work in a flexible working environment.
• Strong communication and collaboration skills adept at working individually or across various functional teams.
• Willing to travel domestically or internationally depending on business needs.    
• Ability to analyze trend data on quality systems metrics using standard statistical techniques such as Minitab
• Possess effective project management skills.

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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.

Operating Company:

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.