Quality Assurance Specialist

About the Organization Harmac Medical Products, Inc, based in Buffalo, N.Y. is a leading, award-winning contract manufacturer of single-use medical devices, serving the global marketplace for more than 40 years. With manufacturing locations in the U.S., Ireland and Mexico, the privately held company provides innovative technical solutions and manufacturing services for leading Fortune 500 med-tech companies and high potential start-ups. Harmac's mission is to change the lives of patients, employees and the communities in which we work.

EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

Category Quality Control

Full-Time/Part-Time Full-Time

Shift First

Number of Openings 1

Salary Range Starting Wage $22-25/hr

Description

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.

Impact

•Monitors and/or performs inspections to ensure compliance of processes and testing required to maintain quality and reliability of products.•Recommends improvements to Quality Assurance processes, QAS documents, and manufacturing processes.•Communicates with direct supervisor and PMT groups to make necessary changes of documents and audits/inspections.

Why work at Harmac?

Harmac provides our employees with more than just a great place to work. Our comprehensive benefits package, employee wellness program, and a suite of perks help our people to get the most out of their workplace experience.

Harmac offers the following perks and benefits to all employees:

• Health, Dental, and Vision insurance

• 401K

• Paid holidays and vacations

• Tuition reimbursement program

• Quarterly bonuses

• Summer scholarships for children and grandchildren of employees

• On-site gym

• Daily free fruit and on-site cafeteria

Starting Wage: $22-24/hr

Position Requirements

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.

This position is currently accepting applications.