Quality Assurance Engineer
5+ years
Skaneateles, NY
Contract
Hybrid
1 month ago
About the role
Job Details:
Title: Quality Assurance Engineer
Location: Skaneateles, NY 13152 (Hybrid / Remote options available)
Duration: 6 Months
Pay Rate: $32.78/hour (W2 - No Benefits)
Work Schedule: 1st Shift
Join a Leading Medical Device Team Driving Quality & Innovation
We are seeking a detail-oriented and analytical Quality Assurance Engineer I to join a leading medical device organization in Skaneateles, NY. This is an exciting opportunity to support critical complaint investigations, quality system improvements, and compliance initiatives within a highly regulated manufacturing environment. Ideal candidates will have a passion for quality systems, root cause analysis, and continuous improvement, with the opportunity to make a direct impact on patient safety, regulatory compliance, and product excellence.
What You’ll Do:
As a Quality Assurance Engineer, you will play a key role in evaluating product complaints, identifying trends, supporting CAPA activities, and ensuring compliance with FDA and quality system standards.
Key Responsibilities:
What We’re Looking For
Required Qualifications:
Preferred Qualifications:
Work Environment:
This role operates within an FDA-regulated manufacturing environment focused on product quality and compliance. Candidates should be comfortable working in a controlled production setting and adhering to required safety and contamination-control procedures.
Physical Requirements:
Why Apply?
If you are passionate about quality engineering and eager to contribute to products that improve lives, we encourage you to apply today.
Title: Quality Assurance Engineer
Location: Skaneateles, NY 13152 (Hybrid / Remote options available)
Duration: 6 Months
Pay Rate: $32.78/hour (W2 - No Benefits)
Work Schedule: 1st Shift
Join a Leading Medical Device Team Driving Quality & Innovation
We are seeking a detail-oriented and analytical Quality Assurance Engineer I to join a leading medical device organization in Skaneateles, NY. This is an exciting opportunity to support critical complaint investigations, quality system improvements, and compliance initiatives within a highly regulated manufacturing environment. Ideal candidates will have a passion for quality systems, root cause analysis, and continuous improvement, with the opportunity to make a direct impact on patient safety, regulatory compliance, and product excellence.
What You’ll Do:
As a Quality Assurance Engineer, you will play a key role in evaluating product complaints, identifying trends, supporting CAPA activities, and ensuring compliance with FDA and quality system standards.
Key Responsibilities:
- Investigate product complaints and analyze service data to determine risk levels and root causes.
- Review and complete quality engineering complaint investigations using multiple quality system inputs.
- Analyze quality data sources, including:
- Complaints.
- Field Corrective Actions (FCA).
- FDA Medical Device Reports (MDR).
- Identify trends and systemic quality issues.
- Prepare and present investigation findings and technical reports.
- Review existing investigations for GMP compliance gaps and develop corrective strategies.
- Support CAPA activities and continuous improvement initiatives.
- Lead or assist with manufacturing corrective/preventive actions using formal problem-solving methodologies.
- Support quality system enhancements and process control improvements.
What We’re Looking For
Required Qualifications:
- Bachelor’s degree in Engineering.
- 1–3 years of experience in the medical device industry.
- Strong analytical and root cause investigation skills.
- Knowledge of FDA cGMP regulations and quality systems.
- Ability to interpret technical drawings and engineering documentation.
- Experience managing multiple projects and priorities effectively.
- Proficiency with Microsoft Office tools and databases.
Preferred Qualifications:
- Experience with 21 CFR 820 and medical device complaint investigations.
- Familiarity with statistical analysis tools such as Minitab.
- Knowledge of ANSI/ISO/ASQC standards.
- Experience supporting CAPA, process controls, and continuous improvement programs.
Work Environment:
This role operates within an FDA-regulated manufacturing environment focused on product quality and compliance. Candidates should be comfortable working in a controlled production setting and adhering to required safety and contamination-control procedures.
Physical Requirements:
- Ability to sit for extended periods.
- Good hand-eye coordination and dexterity.
- Ability to lift up to 40 pounds.
Why Apply?
- Hybrid/Remote flexibility.
- Opportunity to work with a respected medical device organization.
- Hands-on exposure to quality systems and regulatory compliance.
- Collaborative engineering environment with growth potential.
- Potential contract extension based on performance and business needs.
If you are passionate about quality engineering and eager to contribute to products that improve lives, we encourage you to apply today.