Quality Assurance Specialist

3 weeks ago


Gainesville, Florida, United States Exactech Full time
Job Summary:
We are seeking an experienced Validation Engineer to join our team at Exactech. As a key member of our validation group, you will be responsible for providing technical support and expertise in validation and verification (V&V) activities.

About the Role:
The successful candidate will have advanced level technical software proficiency and excellent Quality System knowledge. You will be working closely with cross-functional teams to ensure compliance with medical device industry regulations. This is a fantastic opportunity to work on challenging projects and contribute to the growth and success of our company.

Responsibilities:
- Provide focused, technical engineering assistance regarding V&V requirements of medical device processes, materials, equipment, and methods
- Execute activities related to the compliance of the sterility assurance program
- Participate in the development and execution of robust inspection and test methods for V&V feasibility and qualification projects and standalone studies
- Lead or participate in the validation of corporate software packages ensuring adherence to industry requirements

What We Offer:
- An estimated salary range of $80,000 - $110,000 per year, depending on experience
- A comprehensive benefits package including medical, dental, and vision insurance
- 401(k) plan with company match
- Paid time off and holidays

Requirements:
- Bachelor's degree from an accredited institution required; Master's degree preferred
- Advanced level of technical software proficiency
- Excellent Quality System knowledge required
- Strong time management and project management skills are necessary
- Experience writing IQ/OQ/PQ V&V protocols
- Working knowledge of principles, concepts, and practices of process V&V activities, Risk Management, FDA and ISO Regulations

How to Apply:
If you are a motivated and detail-oriented individual with a passion for quality and regulatory compliance, please submit your application, including your resume and cover letter.

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