Quality Documentation Specialist

About Us

Fluxergy is a rapidly growing biomedical company on the cutting edge of laboratory testing. We're developing a true multi-modal point of care device, the kind of which has never been conceived, and we'd love to have you as part of the team!

Our technologies span many markets including healthcare, veterinary, food safety, and wellness industries. We are seeking self-motivated problem solvers who are excited to help decentralize traditional laboratory infrastructure.

Our roots are squarely rooted in engineering. We pride ourself on critical thinking and solving problems pragmatically, from a modular and systems-level approach. We believe that open and clear communication along with the ability to adapt to changing situations and working outside of your comfort zone is paramount to our success and yours.

Our product: https://vimeo.com/845429891

About the Role

We are seeking an impressive documentation specialist with a desire to learn and an engineering mindset to support Fluxergy's quality and production activities. You will have a hand in driving the business forward. This person will work within the Quality team to ensure documentation records are maintained and support auditing and compliance activities. This is an opportunity to accelerate your career growth through real world experience within a fast-paced bio-tech company. Sound interesting? We'd love to hear from you!

Team Culture

• Collaborative

• Open-minded

• Detail-oriented

• Communicative

• Problem Solvers

• Positive

• Self-starters

What You Will Do

• Maintain a basic understanding of Fluxergy's QMS in relation to ISO 13485/FDA QMSR requirements for IVD manufacturing.

• Demonstrate proficiency and dependability in managing QMS documentation processes to ensure compliance with regulatory standards.

• Provide support to internal Quality teams and external stakeholders in auditing and compliance-related activities.

• Proactively identify trends in documentation and compliance deficiencies.

• Use a solutions-oriented approach to propose and implement optimizations to streamline processes, enhance efficiency, and ensure adherence to regulatory requirements.

What You'll Need to Have

• Demonstrated experience in document processing and/or management.

• An understanding of document control procedures, including change request processing and management, to ensure compliance with regulatory requirements and industry standards.

• Experience in a medical device manufacturing environment is a plus!

• Proficiency in Microsoft Office Suite, particularly in Word, Excel, PowerPoint, Visio, and database programs.

Interview Process

Our interview processes my differ slightly from role-to-role; however, most of our interviews will follow a similar pattern:

• Recruiter Interview

• Hiring Manager interview

• On-site Interview

• Decision

We are an early-stage company and may change our interview process from time-to-time, but our hope is everyone who interviews with us has a positive experience, even if an offer isn't presented.

Benefits

Excellent Medical/Dental Benefits

• 99% medical benefit premiums paid by Fluxergy and covers employee, partner, and dependents
• 100% dental and vision premiums paid for employee, partner, and dependents
• 100% Life Insurance premiums paid for the employee

Work - Life Balance Minded Time Off

• 15 paid vacation days
• 2-week paid winter break
• 7 company paid holidays
• 5 paid sick days

A Work Culture Which Believes in Promoting from Within

• Wear lots of hats / accelerate your career growth!
• We are a flat organization by design - lots of visibility!
• Many of our current leaders started their career with Fluxergy!

Salary Range: $67,000 - $75,000/yr

Additional Information

Fluxergy is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, marital status, age, disability, national or ethnic origin, military service status, citizenship, or other protected characteristic.

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