Compliance and Quality Manager at WellSky

Overland Park, Kansas, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

HealthcareIndustries

Requirements

Bachelor’s degree in Engineering, Quality Management, or a related field
5 years of experience in medical device quality management, compliance, or related fields

Responsibilities

Ensuring certain software products comply with FDA regulations, ONC HTI-1, and other relevant standards
Staying updated on changes in regulations and implementing necessary adjustments to maintain compliance
Developing, implementing, and maintaining the QMS in accordance with FDA requirements and ISO 13485 standards. Ensuring that all processes are documented and followed
Conducting risk assessments and implementing risk mitigation strategies to ensure the safety and effectiveness of software products. Maintaining a risk management file and ensuring it is up-to-date
Planning and conducting internal audits to ensure compliance with QMS and regulatory requirements. Identifying areas for improvement and implementing corrective actions
Evaluating and qualifying suppliers to ensure they meet quality standards. Conducting regular audits of suppliers and managing supplier performance
Developing and delivering training programs for employees on quality management and regulatory requirements. Ensuring that all employees are aware of their roles and responsibilities in maintaining product quality
Leading continuous improvement initiatives to enhance product quality and process efficiency. Implementing best practices and driving a culture of quality throughout the organization
Investigating and managing quality incidents, including non-conformance and customer complaints. Developing and implementing corrective and preventive actions to prevent recurrence

Skills

Key technologies and capabilities for this role

FDA RegulationsISO 13485ONC HTI-1Quality Management SystemRisk ManagementInternal AuditsSupplier QualificationRegulatory ComplianceResponsible AIEmployee Training

Questions & Answers

Common questions about this position

What is the location for this position?

This position is based at WellSky’s World Headquarters in Overland Park, KS.

What are the required qualifications for the Compliance and Quality Manager role?

Candidates must have a Bachelor’s degree in Engineering, Quality Management, or a related field, and 5 years of experience in medical device quality management, compliance, or related fields.

What is the salary range for this position?

This information is not specified in the job description.

What preferred qualifications would make a candidate stand out?

Preferred qualifications include a Master’s degree or professional certification such as Certified Compliance & Ethics Professional, Certified Risk Manager, Certified Quality Engineer, or Certified Quality Manager, along with experience in supporting software development under FDA medical device regulations or AI features.

Does the role involve promoting a specific company culture?

The role includes leading continuous improvement initiatives and driving a culture of quality throughout the organization.

WellSky

Healthcare software and community care solutions

About WellSky

WellSky offers software and services to improve health and community care, making it easier for providers and patients to access and navigate care. Its products, like the WellSky Value Based Care Suite, integrate with Electronic Health Record (EHR) systems to enhance care coordination. WellSky stands out by providing a comprehensive range of solutions, including strategic consulting and revenue cycle management, which help clients operate more efficiently. The company's goal is to enhance care delivery and improve individuals' quality of life through effective solutions.

Reston, VirginiaHeadquarters

1980Year Founded

$34.5MTotal Funding

DEBTCompany Stage

Social Impact, HealthcareIndustries

1,001-5,000Employees

Benefits

High deductible health plan with a generous employer contribution

PPO medical plan

Dental and vision insurance

401(k) plan with access to financial advisors who can provide personal financial guidance at no cost

Robust paid time off, including holidays, vacation, well-being, and volunteer days

Flexible spending accounts (medical and dependent)

Life and disability insurance

Educational assistance

Employee Assistance Plan with free and confidential emotional, financial, legal, and family resources

Risks

Integration challenges with acquisitions like Bonafide may cause operational inefficiencies.

Data privacy issues may arise from collaborations in the nonprofit sector.

Dependency on third-party systems increases exposure to partners' operational risks.

Differentiation

WellSky offers comprehensive solutions across the full continuum of care.

The company integrates with any EHR system to improve care coordination.

WellSky's services include strategic consulting, compliance, and revenue cycle management.

Upsides

Growing demand for integrated care solutions boosts WellSky's market potential.

Value-based care models align with WellSky's offerings, enhancing growth opportunities.

Acquisitions like TapCloud enhance patient engagement and reduce costs.

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