Technician, QA - 2nd Shift

ICU Medical•Southington, CT

17h•Onsite

About The Position

Description Position Summary Supports the Company’s mission to produce safe and effective medical devices. Supports 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. This position is 2nd shift (2;45pm-11:15pm) and is 100% onsite at our Southington, CT manufacturing facility. Essential Duties & Responsibilities Participate in the establishment and/ or revision of quality specifications and standards for raw materials and for 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 their product lines. Participate in MRB review meetings Provide weekly/monthly feedback to management about the progress of actives Completes daily assignments in a safe and effective manner Ensures assignments are completed timely and accurately in accordance with applicable departmental procedures. Complies 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 assignment by supervisor

Requirements

Strong attention to detail and accuracy
Proven ability to work with all levels of the organization
Ability to work in a team environment
Strong communication skills (written and oral)
Ability to plan and prioritize activities
Ability to exercise independent judgment
Knowledge of GMP, and other appropriate regulations and standards applicable to the workplace
Ability to handle confidential information
Basic computer skills
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.
Vision requirements include close vision, distance vision, color vision, peripheral vision and depth perception.
High School Diploma or equivalent, plus three years of Quality Manufacturing experience.
Technical aptitude is required.
Familiarity with US FDA 21 CFR Part 820, ISO 9000/13485/14001.

Nice To Haves

A two-year degree in a technical field is preferred.
Experience in a medical device field is desirable
ASQ certification is desirable.

Responsibilities

Participate in the establishment and/ or revision of quality specifications and standards for raw materials and for 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 their product lines.
Participate in MRB review meetings
Provide weekly/monthly feedback to management about the progress of actives
Completes daily assignments in a safe and effective manner
Ensures assignments are completed timely and accurately in accordance with applicable departmental procedures.
Complies 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 assignment by supervisor