Quality Engineering Analyst

Please Contact:  To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Priyanka Mahant at email address  Priyanka.mahant

himanshi.pandit@generistek.com

We have Contract role Quality Engineering Analyst / Complaint Investigation Engineer for client at Alameda, CA. Please let me know if you or any of your friends would be interested in this position.

Position Details:

Quality Engineering Analyst / Complaint Investigation Engineer- Alameda, CA

Location         : 2601 Harbor Bay Parkway, Alameda, CA 94502 (On-site)

Project Duration: 11 Months of contract

Shift                 : 8:00 AM - 5:00 PM (Mon-Fri)

Pay Rate        : $57.00 per hour on W2

Job Description:

·         BA in Sciences. The incumbent will design and maintain a complaint tracking and reporting system; evaluate medical and non-medical complaints and stability investigation requests and make technical judgment on the nature of the problem; evaluate shipping, manufacturing, equipment, validation, engineering project, testing/inspection results, product specifications, employee training records as well as Basic Operating Procedures, SPC/quality trend data, and or stability reports, as applicable, to determine the root causes of the problem.

·         The reviewer expert its own judgment based on experience to determine the depth of the investigation required associated the level of risk of non-conformance.

·         Maintain a tracking and follow up-system to ensure compliance of Quality Engineering with the FDA Quality Systems Inspection Techniques.

Quality Engineering Analyst (Tracking & Trending)

Position Overview:

·         Our client is seeking a Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis activities within a regulated medical device environment.

·         This role is responsible for performing trending investigations, analyzing complaint data, identifying potential product and process issues, supporting root cause investigations, and driving continuous improvement initiatives.

·         The individual will collaborate closely with Quality, Operations, Manufacturing, and R&D teams while ensuring compliance with FDA and ISO quality system requirements.

Experience Required:

·         2 to 3 years of experience in a:

·         Medical device industry (preferred)

·         Pharmaceutical industry

·         FDA and/or ISO regulated environment

Required Education:

·         Bachelor's Degree in: Biomedical Engineering, or Related Engineering Discipline

Preferred Certifications:

·         ASQ Certified Quality Engineer (CQE) or equivalent certification preferred

Required Technical Skills

·         Candidates should possess experience in the following areas:

·         Quality data analysis and trending investigations

·         Complaint handling and complaint trend analysis

·         CAPA support and root cause investigation methodologies

·         Quality systems within FDA-regulated environments

·         Data analysis and reporting using Excel and related analytics tools

·         Cross-functional collaboration with Quality, Operations, Manufacturing, and R&D teams

Preferred Qualifications:

·         Strong preference for candidates with experience in:

·         JMP

·         Advanced MS Excel

·         SQL querying and data analysis

·         Power BI

·         Basic to intermediate Python programming

·         Quality and complaint management databases

·         Dashboard development and data visualization

Key Responsibilities

·         Perform complaint tracking and trending activities using quality databases and analytical tools.

·         Analyze complaint, CAPA, and quality system data to identify trends, risks, and emerging issues.

·         Support root cause investigations and CAPA activities.

·         Create dashboards, reports, and data visualizations utilizing 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 and support regulatory compliance requirements.

·         Assist with continuous improvement initiatives related to complaint handling and quality trending processes.

·         Present findings, recommendations, and data-driven insights to stakeholders.

The ideal candidate will have:

·         Experience working in a medical device or other highly regulated environment.

·         Strong analytical and problem-solving capabilities.

·         Experience analyzing complaint and quality data.

·         Exposure to CAPA processes and root cause investigations.

·         Ability to communicate technical findings clearly to cross-functional stakeholders.

·         Proficiency with data analytics and reporting tools.

Interview Process:

Two-Step Interview Process

·         Initial Video Interview with Hiring Manager and/or Team Lead

·         Panel Interview with Key Stakeholders

To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Priyanka Mahant at email address  Priyanka.mahant

himanshi.pandit@generistek.com

About generis Tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.