Quality Assurance Engineer I
Chipton-Ross is seeking 5 Quality Assurance Engineers for contract opportunities in Skaneateles, NY.
BASIC QUALIFICATIONS (REQUIRED SKILLS/EXPERIENCE):
o 1-3 years of Medical Device experience
o Medical Device Experience with knowledge of 21CFR820 preferred.
o Investigational research skills
o Experience with any statistical software packages (Minitab a plus)
o Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.
o Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional).
o Knowledge and working application of reading and understanding blueprints and technical drawings.
o Demonstrated strong analytical problem solving (Root Cause Investigations.
o Display a solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools).
o Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
o Ability to multi-task and methodically manage projects.
o Must be able to sit for long periods of time
o Must have good hand to eye coordination and dexterity
o Physical Requirements: Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time.
This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
o Wearing a static protective smock at all times while in the work area
o Wearing a ground wrist strap and plugging that wrist strap into the working table.
o Working in close proximity to other employees.
o Working in an environment that is temperature and humidity controlled.
POSITION RESPONSIBILITIES:
This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.
o Review individual complaints and associated service data to determine risk level and complete investigation into the "as "determined" problem code and cause codes for each complaint.
o Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. Prepare and issue reports based on information analysis.
o Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
o Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products.
o Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
o Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
o Support CAPA and maintenance activities for existing product lines.
o Recommend and/or support projects for improvements to the quality system as approved by management.
REQUIRED EDUCATION:
o A Bachelor of Science degree in Engineering
WORK HOURS:
First shift, full time
Job Location: Skaneateles, NY
Rate: Up to $34.27 DOE
Duration: 11 months
Input Date: 03/13/2025
Last Updated: 06/03/2025
Attention: Christophor Long
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808
Email: clong@chiptonross.com
Website: www.chiptonross.com
ContractJobHunter Home Page