Chipton-Ross - Quality Assurance Engineer I

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: 213782 - Quality Assurance Engineer I
Industry: ENG
Region: NY-Upstate
City: Skaneateles
State: NY
Rate: Up to $34.27 DOE
Duration: 11 months
Description: 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
: Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
Contact: Christophor Long
clong@chiptonross.com
CHIPTON-ROSS, INC.
6926 Rivers Ave
North Charleston, SC 29406

Phone: (843) 554-5800 x179 or (800) 927-9318 x179

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.