Quality Engineer

Quality Engineer

As a Quality Engineer, you will maintain product configuration through a change control process, approve change orders and product structure, and review and approve product, process, and software qualification and validation documentation. You will be instrumental in creating strategies to reduce costs, optimize efficiencies, and improve customer service levels. Participation in Product Review Boards and identifying non-conformance trends are key aspects of this role.

Responsibilities:

• Approve change orders and product structure.
• Review and approve product, process, software qualification and validation documentation.
• Create strategies to reduce costs, optimize efficiencies, and improve customer service levels.
• Participate in Product Review Boards.
• Identify non-conformance trends and develop technical investigation plans.
• Utilize standard statistical analysis and problem-solving techniques to determine product acceptance.
• Evaluate process capabilities and assist R&D Engineering in setting drawing tolerances.
• Perform failure analysis of products returned from the field.
• Conduct technical risk assessments for pre and post-market activities.

Essential Skills:

• 5–7 years of experience in quality engineering.
• Experience with capital equipment and disposable components.
• Proficiency in root cause analysis and quality engineering.
• Understanding of Good Engineering Practices (GEP), including when and how to validate a process.
• Design for manufacturability including DFMEA, stack-up tolerance analysis, and statistical analysis.
• Experience with incoming inspection and component qualification.
• Familiarity with ERP systems like QAD and QMS systems like QCBD.

Additional Skills & Qualifications:

• Support in transferring processes from R&D to manufacturing and into commercial production.

Work Environment:

Join a startup medical device company that is transitioning from design control to commercialization. The company is dedicated to commercializing a novel device for treating glaucoma. With a team of 41 employees, most of whom have worked together for several years, you will be part of a collaborative and innovative environment. The work involves dealing with highly complex devices.

Job Type & Location:

This is a Permanent position based out of Aliso Viejo, California.

Pay and Benefits:

The pay range for this position is $150000.00 - $160000.00/yr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:

This is a fully onsite position in Aliso Viejo, CA.

Application Deadline:

This position is anticipated to close on Sep 17, 2025.