Title: QUALITY ENGINEER
Classification: Exempt, Full Time, 1st Shift
Prepared By: Human Resources
Immco Diagnostics, a Trinity Biotech Company, is looking for a new member to join our rapidly growing QA team. If you are looking for flexibility, and a place to begin or continue your career, Immco Diagnostics could be the place for you!
We are currently seeking a qualified Quality Engineer in the Buffalo, NY. area.
We offer flexible work schedules, 80% paid company insurance as well as full company paid Short Term, Long Term and Basic life insurance. Our schedules are based on a 40 hour work week, Monday through Friday with no nights or weekends required! What more could you ask for...interested? then please read on and let us know!
Reports to: Director of Regulatory/QA
Education Requirements: Engineering degree or specific experience in related field with cGMP and ISO9001/13485 or IVD compliance requirements.
Knowledge of cGMP and ISO 13485 systems
Ability to analyze and interpret data and results
General MS Office computer skills including experience with inventory management systems
Accuracy in recordkeeping and in sorting, checking, counting and verifying items
Problem solving skills and troubleshooting abilities.
Knowledge of product/process validations.
Ability to work cooperatively as a member of a team - position will interact with multiple operational units
Detail oriented and good time management skills
Excellent interpersonal, written, and oral communication skills with ability to articulate with accuracy and detail
Physical Effort: Listed below are the physical demands of the job according to percentage of time performing the tasks including any applicable weight movements.
% of Time Performing Task
Approximate Weight Moved
0 - 30 lbs
30 - 60 lbs
60 - 90 lbs
Repetitive Hand Motion
Summary of Position:
Individuals serving in this position will be responsible for coordinating quality programs in compliance with ISO 13485 including the validation program, supplier quality, and internal audit program.
Job Duties/Key Responsibilities:
Perform product and process validations according to requirements and achieve specified quality objectives; maintain the master validation plan.
Establish statistical inspection plans according to product specifications and quality attributes
Ensure Supplier Quality by qualifying all new vendors, forwarding quality agreements, conducting annual supplier performance evaluation, submitting revisions to the Approved Vendor List (AVL), and conducting supplier audits as needed.
Coordinate the Internal Audit program by creating the internal audit schedule, scheduling audits and following up with any corrective actions required.
Investigate and complete Corrective and Preventive Actions (CAPA) when assigned
Participate with external (regulatory and customer) audits
Writing and updating quality assurance procedures.
Collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations for management review
Assist with updating product risk assessments and other requirements as regulations change.
Provide recommendations for the improvement of existing processes
Coordinate training system records and maintain files per training matrix.
Other projects as assigned.
If you meet these qualifications, please apply or feel free to message with any questions.
We have Medical, Dental, Vision, Company Paid Basic Life, Short Term Disability, Long Term Disability, Flexible Spending Accounts, Employer Assistance Program, and we do not require nights and weekends.
The above statements shall not be construed as a complete description of all the work requirements.
Trinity Biotech is an equal opportunity employer. We evaluate qualified applicants, without regard to race, color, religion, national origin, sex or gender, age, disability, veteran status, sexual orientation, gender identity or expression, genetic information, including the perception that a person has any of those characteristics, or any other consideration made unlawful by applicable law. Trinity Biotech is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please call Human Resources 716-568-8601 and let us know the nature of your request and your contact information.