To Discuss more about this job opportunity, please reach out to Anwesha Mohapatra (LinkedIn URL -Anwesha Mohapatra - Collabera | LinkedIn), email your updated resume at Email - anwesha.mohapatra@collabera.com. Thank you!

Pay Range: $45/hr to $50/hr

Job Title: Quality Engineering Analyst

Location: Alameda, CA 94502

Work Type: Onsite

Contract Duration: 12 months with possible extension

Job Summary:

The Quality Engineering Analyst will support complaint tracking, quality data analysis, trending investigations, and reporting activities within a regulated medical device environment. The role will evaluate complaint and quality data, identify potential product and process issues, and support root cause investigations and CAPA activities. The analyst will collaborate with Quality, Operations, Manufacturing, and R&D teams to assess quality risks and support continuous improvement. The position requires strong analytical capabilities and an understanding of FDA and ISO regulated quality systems. The ideal candidate will be comfortable working with quality databases, analytical tools, and large data sets.

Key Responsibilities:

• Maintain complaint tracking and reporting systems to support quality engineering activities and regulatory compliance.
• Evaluate medical and non medical complaints, stability investigation requests, and quality events to determine the appropriate level of investigation.
• Analyze shipping, manufacturing, equipment, validation, engineering, testing, inspection, product specification, training, SPC, quality trend, and stability data to identify potential root causes.
• Perform complaint tracking and trending activities using quality databases and analytical tools.
• Analyze complaint, CAPA, and quality system data to identify trends, risks, recurring issues, and emerging product or process concerns.
• Support root cause investigations and CAPA activities by evaluating relevant quality and operational data.
• Develop reports, dashboards, and data visualizations using Excel, Power BI, JMP, SQL, and Python.
• Partner with Quality, Operations, Manufacturing, and R&D teams to investigate product and process concerns.
• Document investigative findings, technical assessments, recommendations, and supporting evidence in accordance with quality system requirements.
• Maintain tracking and follow up systems to support timely completion of quality engineering activities and regulatory requirements.
• Present data driven findings and recommendations to cross functional stakeholders.

Required Qualifications:

• Bachelor's degree in Biomedical Engineering, Engineering, Sciences, or a related discipline.
• 2 to 3 years of experience in a medical device, pharmaceutical, or FDA or ISO regulated environment.
• Experience with quality data analysis and trending investigations.
• Experience with complaint handling and complaint trend analysis.
• Exposure to CAPA processes and root cause investigation methodologies.
• Experience working with quality systems within an FDA regulated environment.
• Strong MS Excel skills and experience analyzing and reporting on large data sets.
• Strong analytical, problem solving, documentation, and communication skills.
• Ability to collaborate effectively with Quality, Operations, Manufacturing, and R&D teams.

Preferred Qualifications:

• ASQ Certified Quality Engineer certification or equivalent certification.
• Experience with JMP.
• Advanced MS Excel experience.
• Experience with SQL querying and data analysis.
• Experience with Power BI.
• Basic to intermediate Python programming experience.
• Experience with quality and complaint management databases.
• Experience developing dashboards and data visualizations.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)