Do you enjoy quality assurance and compliance? Do you learn quickly and want to help make a difference in the healthcare industry? Would you like to use your skills in a collaborative and fast-paced work environment?
If so, this may be the perfect role for you! Please review the details below and click "Apply" today if this role excites you as a potentially amazing fit!
Position Purpose:
The position has overall responsibility for quality assurance, control, and documentation functions including the development and implementation of both quality policies and systems at AvaSure.
In addition, this position manages the overall regulatory compliance readiness, and inspection management and maintains the existing compliance registrations.
The position is responsible for execution and implementation of compliance and quality procedures and processes.
Education & Experience
Bachelor's degree required.
Engineering degree preferred.
At least 5 years of experience working in operations, quality assurance, and/or quality control in a regulated medical environment required.
Internal (audit corrective and preventive action assignment, projects prioritization) and external (inspections corrective and preventive actions) negotiation skills are required.
Functional knowledge of medicinal products and device manufacturing and testing is preferred.
Functional knowledge of laws, regulations, and regulatory agencies regarding medical technology best practices is preferred.
Functional knowledge of internal documentation for medical technology is preferred.
Experience with medical technology and electronics regulation.
Demonstrated competency of 21 CFR 820, MDD, ISO 13485, ISO 14971, IEC 60601, IEC 62304 standards a plus.
Competencies & Work Style:
Professional Communication Proficiency
Organizational and planning skills
Ethical Conduct
Indirect Management
Process Focused
Supervisory Requirements
Direct reports may be assigned in the near term.
Work Environment & Physical Demands:
Work is generally independent and collaborative in nature
While performing the essential functions of this job, the employee is frequently required to sit for long periods of time and use a computer.
This position is full-time.
The position is hybrid with 1 day in the office in Belmont, MI and the remaining days remote from home.
Why AvaSure?
As the pioneer and expert in inpatient telehealth, AvaSure has provided safer environments for over 1 million patients, with over 50 million live monitoring hours.
By continuing to reduce adverse events, and by optimizing workforce efficiencies for the nation's top health systems, AvaSure has consistently lowered the cost of care while providing safer, more efficient healthcare for everyone.
Benefits & Perks
AvaSure sponsored Medical, Dental & Vision
Safe Harbor 401K with Employer Matching up to 4%
HSA Employer Contributions, Employer Paid Life, Short-term and Long-term Disability, and AD&D Insurance Plans
Flexible Time Off Plan & Paid Holidays
Parental Leave
Generous Tuition Assistance & Continuing Education Reimbursement available
Employee Referral Bonus
Diversity creates a healthier work environment: AvaSure is an Equal Employment Opportunity/Affirmative Action employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.
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