Senior Quality Engineer - Laguna Woods, United States - Sonendo

Sonendo Laguna Woods, United States

3 weeks ago

Description

Overview:
Sonendo, is a medical technology company with a unique mission to lead the transformation of dentistry through Sound Science.

We are currently building a high-performance team with a passion for creativity and innovation that is committed to collaboration and integrity.

We believe our success is based on developing disruptive technologies, and we strive to achieve excellence in our products and services by attracting energetic, entrepreneurial individuals who are committed to this vision.

Responsibilities:

The Senior Quality Engineer will be responsible for the effective design and manufacture of medical devices, compliance with internal procedures and external regulations, and the efficient execution of business activities thereto related.

The Senior Quality Engineer will be expected to:
Monitor and ensure compliance to internal quality system and external industry regulations

Provide quality support to determine process improvements, lead investigations, root cause analyses, corrective action, implementation activities and interface with all cross functional departments and/or suppliers to increase product quality.

Provide technical expertise regarding validations, verification and qualifications
Perform investigations for NCMRs, SCARs, and CAPAs

Participate in Risk Management activities ensuring compliance with ISO 14971, including but not limited to the completion of FMEAs, Risk Assessments, and Risk Management Plans/Reports.

Develop and maintain inspection and quality control procedures
Lead Supplier Management activities, including the execution of supplier qualifications and supplier audits
Ensure compliance with design control procedures
Maintain compliance with Quality System procedures and company policies
Maintain and develop procedures related to product realization and internal processes

Qualifications:
B.S. in Engineering, Life Science or related discipline required
Minimum of 5 years work experience in a regulated industry required (medical device preferred)
Minimum of 4 years work experience in quality engineering or quality assurance role
Working knowledge of 21 CFR Part 820, ISO 13485 pertaining to class II/class IIb medical devices
Demonstrated knowledge of statistical methods and principles
American Society of Quality Certified Quality Engineer (ASQ CQE) or Certified Medical Device Auditor (CMDA) a plus
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard practices

Physical Requirements:

Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.

Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards
Must be able to lift and carry up to 25 lbs
The ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations.
Must be able to remain in a stationary position for 50% of the time.
Must be able to occasionally move about inside the office to access file cabinets, office machinery, etc.
The ability to observe details at close range (within a few feet of the observer).

Compensation:
We pay competitively. Base salary range is $91,000 - $121,000. Other paid compensation and benefits may be available.
Additional Information

Sonendo offers a competitive benefits package and a collaborative, motivating work environment where you will be encouraged to innovate continuously; This is a place where you will be encouraged to actively participate, and your ideas can have a direct impact on the success of the organization.

If you are interested in applying for this position, please apply online.
No recruiters, please.
Sonendo, Inc. is an Equal Opportunity Employer
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