Nobel Biocare Quality Engineer, Manufacturing (On-Site Yorba Linda, CA)

Job Summary

The Quality Assurance Engineer is responsible to ensure that production processes remain in a state of control, validation and verification activities are robust, and processes consistently produce medical devices that meet specifications. This role supports and ensures compliant execution of New Product Introduction and manufacturing Life Cycle Management activities and drive continuous improvement activities.

Primary Duties & Responsibilities

• Support the translation of process risk into PFMEA controls, control plans, standard work and -for-purpose in-process inspection.
• Ensure validations and verifications are robust, and oversee revalidation cycles.
• Ensure manufacturing-related procedures are strictly applied.
• Partner with manufacturing engineering to optimize inspection and testing methods.
• Participate in NPI and Lifecycle projects to ensure compliant execution thereof.
• Document, evaluate and track production non-conformances, and lead or facilitate containment, root-cause analysis, NCR and CAPA actions
• Use process, inspection and nonconformance data to detect variation, confirm capability and drive continuous improvement
• Partner with Operations and Engineering to follow standard work, manage changes and maintain accurate, traceable records.
• Support critical and time-sensitive topics, such as recalls, production issues, internal and external audits, corrective and preventive action
• Support the creation, implementation, training and continuous improvement of Quality Assurance processes.
• Act as a consultant for project teams and individuals related to application and interpretation of internal and external procedures, guidance, standards and regulation to find pragmatic ways to achieve appropriate and compliant documentation of activities.

General Quality Accountabilities

• Support internal, and external audits
• Lead supplier audits

Job Requirements

• Bachelor's degree in Engineering, Life Sciences or related disciplines.
• 6+ years of quality engineering experience in the medical device industry or equivalent regulated industry in a manufacturing environment.
• Hands-on expertise in root cause analysis tools such as 5-Why, Fishbone, Lean or Six Sigma methodologies.
• Practical experience with risk management tools (PFMEA).
• In-depth understanding and knowledge on standards and regulation including but not limited to:
• ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes.
• ISO 14971 - Medical devices - Application of risk management to medical devices.
• IEC 60812 - Failure modes and effects analysis (FMEA and FMECA).
• 21 CFR 820 QMSR - Quality Management System Regulation (FDA).
• Fluency in English.

Preferred Qualifications

• Master's Degree preferred.
• Exercises independent work style and judgment in complex quality and compliance topics.
• Applies risk-based thinking.
• Effective verbal and written communication skills across functions.
• Strong analytical, statistical, and documentation capabilities.
• Objective problem-solving skills with the ability to make firm, risk-based quality decisions under pressure.

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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.

For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan $105,200 - $128,600

Operating Company: Nobel Biocare

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.