Job Description

Swoon partners with a global leader in medical device manufacturing to find a skilled Quality Assurance Analyst for their Skaneateles, NY office . This hybrid position, with the option for remote work for the right candidate, is a one-year contract with high potential for extension or conversion based on performance. In this role, you will be responsible for investigating and analyzing quality engineering complaints, identifying systemic issues, and driving corrective actions. Your expertise in FDA regulations, statistical analysis, and quality systems will play a key role in ensuring product safety and compliance. If you're passionate about driving continuous improvement in a dynamic, innovative environment, apply today!

Here are the details:

Location: Flexible hybrid in Skaneateles, NY office – open to remote for the right candidate

Duration: Initial one-year contract with high potential to extend/convert based on performance

Pay Rate: $28-29/hr W2

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.

• 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.
• 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.
• Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
• Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products.
• 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.
• Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
• Support CAPA and maintenance activities for existing product lines.
• Recommend and/or support projects for improvements to the quality system as approved by management.

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.

EDUCATION/EXPERIENCE REQUIRED:

• A Bachelor of Science degree in Engineering
• 1-3 years of Medical Device experience

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