Position Summary
The Quality Assurance Technician is responsible for supporting the Company’s mission to produce safe and effective medical devices. Support the Quality Management System (QMS) through driving dispositions for non-conforming product and improving test methodology. Assist the production / quality teams in collecting and analyzing data for measurement systems analysis, capability studies, design of experiments, etc.
Essential Duties & Responsibilities
- Participate in the establishment and/ or revision of quality specifications and standards for raw materials, in-process and finished products.
- Support the development and revision of inspection and testing procedures for raw materials, in-process and finished products
- Support investigations on product defects to identify root cause and potential corrective action.
- Provide technical assistance and support to the manufacturing teams for designated product lines. Provide guidance in the completion of required documentation and records.
- Participate in MRB review meetings
- Provide weekly/monthly feedback to management about the progress of activities
- Ensure assignments are completed safely, effectively, timely and accurately in accordance with applicable departmental procedures.
- Comply with the requirements, responsibilities, and authority as outlined in the System Manual and SOP’s. Must keep aware of changes in GMP and other regulatory requirements that affect the company quality plan.
- This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
- Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement
- Other duties as assigned or directed
Knowledge & Skills
- Strong attention to detail and accuracy
- Strong communication skills, with a proven ability to work with all levels of the organization
- Ability to work in a team environment
- Ability to plan and prioritize activities, and exercise independent judgment
- Knowledge of GMP, and other appropriate regulations and standards applicable to the workplace
- Ability to handle confidential information
- Demonstrated capability in the use of a computer
- Vision requirements include close vision, distance vision, color vision, peripheral vision and depth perception.
Minimum Qualifications, Education & Experience
- High School Diploma or equivalent. Technical aptitude is required. A two-year degree in a technical field is preferred.
- Three years of Quality Manufacturing experience.
- Familiarity with US FDA 21 CFR Part 820, ISO 9000/13485/14001.
- Experience in a medical device field is desirable
Work Environment
- While performing this job, an employee is required to stand, walk and use hands to handle materials. The employee is frequently required to reach with hands and arms and to talk and hear. The employee is occasionally required to stoop, kneel, or crouch.
- This position is occasionally required to lift up to 50lbs and move more than 100lbs.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel less than 5% of the time
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Quality
Primary Location
US-CT-Southington
Schedule
Full-time
Shift
Day Job
