Job Description:

PURPOSE :

Assists in assuring medical devices are designed and manufactured with high quality and reliability, within all domestic and international regulatory Quality Management System (QMS) requirements and meet or exceed customer expectations.

ACCOUNTABILITIES :

• Plans and conducts inspection of equipment validations.
• Responsible for the Environment Monitoring Program
• Responsible for monthly/quarterly/bi-annual/yearly product testing and analysis of data

• Collaborate with Post Market Surveillance – Investigations, track and trend of complaint data, PFA/HHE meetings
• Yearly Periodic Risk Assessment review
• Assist with external/internal audits
• Update create SOPs/ECOs and any related documents
• Interact with other departments to resolve development, manufacturing and/or customer issues.
• Leader model and coach other team members in EBS and QA

Job Requirements:

EXPERIENCE :

• Bachelor’s degree from a four-year College or University in an engineeringdiscipline or 3+ years of QA Engineering experience in lieu of education
• 2+ years of Quality Assurance Engineering experience within manufacturing or equivalent
• Must have knowledge of basic computer software applications such as Microsoft Word, Excel, PowerPoint, etc. orequivalent.
• Must reside within a commutable distance to Yorba Linda, CA.

CRITICAL EXPERIENCE:

• GeneralFDAandinternational medical deviceregulations knowledge (i.e.,21CFRPart 820,ISO13485,MDD,JPALandCMDR)
• Compliance certifications highlypreferred.
• Must have SAP knowledge
• Knowledge of ISO standards
• Internal/External audits
• Quality seminars, webinars and other quality events

PREFERRED SKILLS:

• Ability to analyze trend data on quality systems metrics using standard statistical techniques such as Minitab
• Must have good project management, communication and collaborative skills working individually or with various functionalteams
• Must be hands-on and able to multi-task to address existing and potential QA issuesroutinely.
• Must be available to work on different rotations or hours depending on businessdemands.
• Mustbeavailabletoworkinaflexibleworkingenvironmentandbewillingtotraveldomesticallyor internationally depending on businessneeds.

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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.

$64,100 - $96,200

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.