QUALITY ASSURANCE ENGINEER

Integrated Resources Inc.; Madison (WI); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in workforce solutions is seeking a Quality Assurance professional to ensure compliance with Medical Device regulations. The ideal candidate will have a Bachelor’s degree in Engineering or a Technical degree with relevant experience. This role requires a solid understanding of quality systems, process control methodologies, and the product development lifecycle.

Qualifications

• 1-2 years of experience in Quality Assurance.
• Understanding of FDA CFR 21 820 and ISO 13485.
• Familiarity with product development lifecycles.

Responsibilities

• Understanding Medical Device QMS and regulatory requirements.
• Control methodologies in manufacturing and production processes.

Skills

Quality Assurance

Medical Device QMS

Process Verification and Validation

Education

Bachelor's Degree in Engineering

2 Year Technical Degree

Job description

IRI believes in commitment, Integrity and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.



We’ve stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.



Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients’ success.

Job Description

1. Bachelors Degree in an engineering or technical discipline (or non-technical degree with 2 years of experience in manufacturing, engineering or quality assurance experience in addition to any other experience requirements).
2. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
3. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.

Qualifications

MUST HAVE: 1-2 Years experience in Quality

MUST HAVE: Bachelors Degree in Engineering Field or 2 year TECH DEGREE with Work Experience.

Additional Information

Regards,
MonilPatel
Technical Recruiter
Integrated Resources, Inc
[phone] Ext.338
monil @irionline.com