Senior Quality Engineer - Laguna Woods, United States - Sonendo

Description

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:

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