Quality Specialist

• Location 48225 Lakeview Blvd,Fremont, CA, 94538,United States
• Base Pay $27.00 - $30.00 / Hour
• Employee Type FT Non-Exempt
• Required Degree High school
• Manage Others No

• Name Roxanne
• Email

• Assist Audit Lead and/or delegate in preparing and hosting audits, ensuring all required documentation and processes are readily available.
• Respond promptly and professionally to customer inquiries related to quality issues, providing accurate information and resolution support.
• Complete and maintain weekly quality checklists to ensure compliance with established standards and procedures.
• Record and track quality events, such as quality tickets, in accordance with company protocols and regulatory requirements.
• Conduct periodic reviews of supplier performance and compliance, documenting findings and recommending next steps
• Review batch records for accuracy and completeness to ensure compliance with quality standards and regulatory guidelines.
• Support onboarding and training activities for new hires, ensuring understanding of quality processes and compliance requirements.
• Review Safety Data Sheet for accuracy and compliance
• Scanning and filing relevant documents in compliance with regulatory requirements
• Assist in conducting process audits to verify adherence to standard operating procedures and identify areas of improvement
• Manage the revision and approval process for quality-related reports, ensuring timely updates and accurate documentation.
• Track and maintain logs for Key Performance Indicators (KPIs) to monitor quality performance and support continuous improvement initiatives.
• Maintain clean and organized work areas.
• Collaborate with other employees and departments as needed.
• Complete compliance training/continuing education requirements by the noted deadlines.
• Ensure proper execution of appropriate Steri-Tek Standard Operating Procedures.
• Assist in the training of other employees under the direction of the Quality Management team or authorized delegate.
• Team player and willing to work with others across the business.
• Ability to work independently under general guidelines and supervision.
• Ability to report mistakes, faults, and accidents to management.
• Ability to adapt to changing duties and responsibilities.
• Other duties as assigned by the Manager.

• High school diploma or general education degree (GED); or 2 – 4 years of related experience and/or training; or equivalent combination of education and experience.
• Ability to effectively read, write and verbally communicate in English.
• Able to write clearly and concisely to complete paperwork associated with the job.

• Bachelor's degree from four-year college or university; or 1- 2 years related experience and/or training; or equivalent combination of education and experience
• 1-2 years of experience in manufacturing or medical device/pharmaceutical industry.

• Continually sitting, use of hands, and reaching
• Frequently standing and walking
• Occasionally stooping, crouching or crawling, climbing and balancing
• Occasionally lifting moderate weight (25-50) lbs.

• Light – office environment
• Moderate – Warehouse environment
• Extreme Conditions – may work in hot/cold temperatures

The Quality Specialist I is an entry-level position focused on supporting Quality activities and basic document reviews to ensure compliance with ISO 13485, ISO 11137, and other regulatory requirements. This position provides essential support to the Quality Assurance team by performing tasks such as data collection, record review, document handling, and performing production batch record Quality checks. While customer interaction is limited, strong customer service skills are required.

Key responsibilities include supporting audits, responding to customer inquiries, maintaining weekly checklists,documenting Quality Events (e.g., Quality Tickets) reviewing suppliers, conducting batch record quality checks, supporting onboarding and training support, reviewing Safety Data Sheets (SDS), scanning and filing documents, updating processing reports, reviewing and correcting folders, tracking and maintaining Key Performance Indicator tools(KPIs), and revising documents. Basic training for others is an expectation for this role.

This is an onsite position in Fremont, CA. The working hours are from 8:00AM to 4:30PM, Monday through Friday.