CAREER PORTAL

Quality Engineer

Yoh is hiring a Quality Engineer for our Santa Fe Springs client. In the Quality Engineer role you will support manufacturing and work cross-functionally to resolve technical problems.  They are seeking a highly motivated and independent engineer with a strong background in process Failure Modes and experience with the application of ISO 14971 for process FMEA and process validations (IQ/OQ/PQ) to mitigate risks. This position supports or provides solutions to broad problems, accomplishes assignments of various complexity, develops protocols for design, and/or process activities (including those related to verifications or validations), determines criteria and subsequently generates summary (or final) reports.
 
Industry: Medical Device
Location: Santa Fe Springs, CA
Compensation: $80k - $90k annually  
Type: Direct Hire

Job Functions

• Collect, analyze, and present data using statistical methods to support quality decision-making.
• Utilize quality tools to drive continuous improvement, including process flowcharting, Pareto analysis, correlation and regression analysis, significance testing, design of experiments (DOE), statistical process control (SPC), gage repeatability and reproducibility (GRR), and trend analysis.
• Assist in the development and execution of key QMS deliverables, including Advanced Product Quality Planning (APQP), complaint analysis, risk analysis, Failure Mode and Effects Analysis (FMEA), Corrective and Preventive Actions (CAPA), and process/equipment/software verification and validation.
• Plan and/or conduct process and equipment validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support process capability assessments by planning and executing Process Capability studies.
• Monitor engineering production processes and products to ensure compliance with both internal and external quality standards.
• Recommend modifications to improve quality and optimize production within equipment capabilities.
• Track and analyze key performance metrics to assess and improve operational performance.
• Collaborate with cross-functional teams to address production and quality issues with minimal supervision.
• Maintain adherence to QMS procedures, work instructions, and forms to support quality and regulatory compliance.

Education, Licensure and/or Experience

• Bachelor’s degree in engineering, life science or other technical discipline.
• 3+ years in quality assurance working in a medical device/pharmaceutical manufacturing environment.
• FDA (CFR 820, 210 and 211), and ISO 13485 quality management systems experience.
• Knowledge of statistics and Minitab, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications
• Strong analytical abilities to identify, articulate, research, gather data, and solve problems by making informed decisions based on available information.
• Exceptional technical writing skills, with the ability to create and update internal and external documentation as well as author technical reports.
• Demonstrated ability to thrive in high-pressure environments requiring a strong sense of urgency, analytical problem-solving, and interpersonal skills. Capable of managing multiple complex tasks simultaneously while excelling as a team leader, member, and independent contributor.
• Excellent verbal and written communication skills, with the ability to clearly present and justify quality requirements.
• Strong attention to detail, ensuring precise measurements, accurate documentation, and thorough review of quality records.
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Estimated Min Rate: $80000.00
Estimated Max Rate: $90000.00

Note: Any pay ranges displayed are estimations.  Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.  All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit  https://www.yoh.com/applicants-with-disabilities  to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.  All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.