Job Information
Harmac Medical Products Quality Assurance Specialist in Buffalo, New York
Job Summary
The Quality Assurance Specialist supports quality assurance activities. The responsibilities include developing and implementing quality assurance policies, methods and procedures, reviewing documentation for completeness and accuracy, conducting tests, inspections and investigations, identifying production, process, or product issues, training, and presenting solutions. This position will work 7 am-3:30 pm Monday- Friday.
Job Duties
•Preparing, updating, and implementing quality assurance policies, methods, and procedures. •Creating training materials and operating manuals. •Performs and/or assist in training and cross-training of specific departmental needs, working within a team environment. •Performs routine inspections and quality tests using set standards, STMs and SOPs. •Supports company complaint program including performing analysis of product returns, leading investigations, management of metrics and database administration. •Oversees and/or administers testing programs as necessary. •Performs as an Auditor and/or Lead auditor for QMS and EMS audits. •Identifying and resolving quality, workflow and production issues. •Ensuring that standards and safety regulations are observed. •Addressing and discussing issues and proposed solutions with superiors. •Documenting quality assurance activities and creating reports. •Reviews requested documents and records for completeness and accuracy. Attaches documents and records to correspondence for reply by other department employees where necessary. •Through document and record review and/or product testing, establishes conformity and releases product for use and/or shipment where required. •Maintains files and controls records to show status of actions in processing correspondence and or controlling documentation. •Compiles data from records to prepare periodic reports. •Investigates discrepancies in reports and records and confers with personnel in affected departments to ensure accuracy and compliance with procedures. •Making recommendations for improvement. •Demonstrates Harmac’s core values of honesty, integrity, and respect. •Other duties as assigned.
Skills/Technical Skills
•Basic computer skills associated with traditional PC based software such as Microsoft Office required. •Excellent data collection and analysis with attention to detail skills. •Auditing and/or review of processes, products, and documentation. •Process and/or product inspection, and performance of testing for environmental monitoring.
Knowledge
Working knowledge of inspections/audits, standard operating procedures, and industry standards. Working knowledge of tools, methods, and concepts of quality assurance.
Education
High school diploma/GED required. Associate or Bachelor Degree preferred. ASQC, CQT certification or certification in quality assurance is a plus.
Experience
Three to five years related experience and/or training; or equivalent combination of education and experience.
Minimum Salary: 22 Maximum Salary: 25 Salary Unit: Yearly