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Junior Quality Engineer

4 months ago

Buffalo, United States Safetec of America Inc Full time
About Us:For over 30 years, Safetec of America, Inc. has been your trusted source for infection control, first aid, and compliance products. We are a family-owned, local business that treats our employees like family, leading to high employee retention. Join our diverse company, recognized as a WNY Best Place to Work and for excellence in manufacturing

Job Summary:We are seeking an entry-level Quality Engineer to ensure product quality throughout the product life cycle using industry best practices in production and process controls. The successful candidate will also support the maintenance and implementation of Safetec's Quality Management Systems to meet company objectives.

Responsibilities:
  • Support the auditing and release of company products by reviewing product batch records, focusing on Good Manufacturing Practices (GMP). This includes evaluating product documentation, records, and QC test results. Communicate with responsible parties to address any required record updates or deviations, and assist in resolving these issues.
  • Track and update periodic QA/Document Control metrics and dashboards.
  • Maintain communication with appropriate departments on expected release dates, as well as release delays.
  • Review of Quality System components such as BMR, BPR, APR, SOP, Technical Files, etc.
  • Compile applicable data for Annual Product Review (APR) maintaining organization and consistency with attention to detail.
  • Participate in batching and packaging validation duties to include planning, drafting, execution, and completion of validation duties.
  • Participate in root-cause analysis and corrective and preventative actions (CAPA, NCR).
  • Support Quality Objectives, including analysis and regular trending of key quality system elements
  • Generate or update standard operating procedures to define and improve quality system function
  • Participate in the implementation and monitoring of the training program.
  • Participate in and support quality audits (internal and external), troubleshooting efforts, and other Quality System processes.
  • Other duties as assigned by department management.
Experience Requirements:
  • 0-2 years of experience with Quality System implementation in compliance with FDA, ISO 13485, or other regulated industry Quality Management System guidance.
  • Motivated self-starter with the ability to work independently and systematically.
  • Demonstrated growth mindset and flexibility in thinking.
  • Strong problem-solving skills using process knowledge and data.
  • Willingness to contribute to solutions and continuous improvement.
Education Requirements:
  • Bachelor's Degree in an engineering/scientific discipline or comparable work experience in an FDA-regulated industry.
  • Exposure to courses related to the Drug Manufacturing Industry/FDA terminology is a plus.
  • ASQ certification is a plus.

If you're looking for a rewarding opportunity to grow your career in a supportive and dynamic environment, apply today to join the Safetec family