Job Title: Quality Engineer
Duration: 12-month contract
Job Location: Skaneateles, NY
Pay Rate: 33.00 USD per hour on W2
Shift Timing: Monday to Friday, First Shift
Job Description:
This description outlines the employment prerequisites and job responsibilities for the position of Engineer, Quality Complaint Investigation.
II. ESSENTIAL FUNCTIONS:
This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.
Ø 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.
Ø 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.
Ø Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
Ø Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products.
Ø 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.
Ø Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
Ø Support CAPA and maintenance activities for existing product lines.
Ø Recommend and/or support projects for improvements to the quality system as approved by management.
III. QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED:
• Medical Device Experience with knowledge of 21CFR820 preferred.
• Investigational research skills
• Experience with any statistical software packages (Minitab a plus)
• Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.
• Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional).
• Knowledge and working application of reading and understanding blueprints and technical drawings.
• Demonstrated strong analytical problem solving (Root Cause Investigations).
• 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).
• Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
• Ability to multi-task and methodically manage projects.
IV. EDUCATION/EXPERIENCE REQUIRED:
• A Bachelor of Science degree in Engineering
• 1-3 years of Medical Device experience
...negotiation skills to secure deals for freight transportation while managing customer shipments from pickup to delivery. No prior experience is necessary; our best in-class paid freight broker training and mentorship program will teach you everything you need to know...
...Title: Change Manager Location:100% onsite in Mossville IL Duration: 2+ years 5 days a week in the office. No exceptions. This is for all of Resource Industries. Need to be local to Peoria. Skills: ~3-5 years of organizational years...
Looking for an experienced investigator to conduct surveillance in and around the Boston area. Must be result oriented, take responsibility... ..., we ask that you have your own computer and vehicle. \\ Defense Investigators Group Inc. is a well established company that...
...satisfaction are key. What You'll Do: As a Pre-Construction and Estimating Project Manager, you'll be the driving force behind our... ...exceptional results. Flexible Work Options: Hybrid or fully remote opportunities available based on location (preference for candidates...
...oriented and organized Bookkeeper to manage the financial records and transactions of our law firm. The ideal candidate will have experience in law firm accounting and be adept at maintaining compliance with trust accounting and other legal-specific financial...