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About The Position
Flywheel is seeking a Quality Manager to join our fast-paced and growing team. This is an exciting opportunity for a self-motivated person with a comprehensive knowledge and passion for software validation and verification compliance procedures. The Quality Manager will be responsible for maintaining the organizational compliance and regulatory maintenance procedures as they pertain to software engineering and related platforms. The goal of this position is to oversee and improve these software validation, verification, and documentation processes following company policies and procedures to ensure consistency and compliance, as well as identifying any gaps or risks which require mitigation.
In this role, you will work closely with Product Engineering, Research and Development along with other departments as needed reporting directly to the Sr. Director of Regulatory Affairs. We’re highly responsive to customer needs and constantly strive to make a positive contribution to the biomedical and life sciences communities we serve. We focus on teams working together to formulate efficient strategies for success.
Team members are recognized and rewarded when advocating for customer success and satisfaction over other concerns. We value self-motivated, creative iniduals who work well in a collaborative environment constantly generating and sharing new ideas and solutions with the team.
Flywheel has a comprehensive benefits package and encourages a balanced work life and home life.
- Oversee the Software Quality Assurance procedures to ensure all policies and procedures are being adhered to.
- Work closely with the Quality Assurance teams on software validation, verification and documentation procedures followed company policies and procedures.
- Identify and report any gaps or inconsistencies within these functions and develop and initiate corrective action and mitigation plans.
- Maintain knowledge of regulatory guidelines and ensure all functions within scope are adhering to these guidelines and that policies are updated as needed.
- Take a lead in the development, management, and implementation of quality compliance policies, procedures and guidelines to direct and carry out the objectives of Flywheel’s quality program.
- Oversee Quality Assurance compliance adherence and effectiveness across departments.
- Investigate, respond to, and possibly lead remediation activities around quality compliance incidents reported by personnel or clients.
- Actively participate in internal annual company wide audits in conjunction with department leads and provide corrective action reports as needed.
- Actively participate in external audits as needed.
- Identifying software quality non-compliance in a timely manner to allow Flywheel management to address and correct potential impacts before they become major risks to the company.
- Other responsibilities as required and assigned by the Sr. Director of Regulatory Affairs.
What would make you a great fit
- Bachelor’s Degree in Computer Science, Healthcare Information Technology or related field or commensurate experience.
- Be familiar with regulations, guidelines and laws regarding validation procedures in biomedical imaging software.
- Experience assisting in audits of organizations in biomedical software or related industries.
- Experience developing and maintaining standard operating procedures and company compliance standards.
- Oversight of corporate/industry software validation programs adhering to applicable industry standards and regulations:General Principles of Software Validation, FDA Guidance for Industry; Process Validation: General Principles and Practices, Eudralex: Computerised Systems EU Software Validation Requirements; Software Development Life Cycle Processes; HIPAA, GCP, GDPR – Regulations governing PII and PHI; 21 CFR Part 11, EU Annex 11, 21 CFR Part 820 – Healthcare regulations governing electronic records and signatures, quality and security in research and devices; SOC 2, ISO 27001 and/or ISO 13485, ISO 27799, ISO 9001-Quality Management Systems.
- Administering Quality Management Systems for the storage and maintenance of company compliance documentation.
- 3 years experience managing the software quality compliance and regulatory functions for a company, preferably a biomedical informatics company supporting clinical trials both nationally and internationally.
Flywheel is the leading research data platform that’s transforming the way biomedical and imaging data are managed at leading life sciences, clinical, and academic institutions globally.
Flywheel provides a comprehensive research data solution with all the tools needed for curation, imaging processing, machine learning workflows, and secure collaboration. By leveraging cloud scalability and automating research workflows, Flywheel helps organizations scale research data and analysis, improve scientific collaboration, and accelerate discoveries.
GO STEADY WITH LEVITY
The alchemy of effective teamwork happens when we each take ownership of both the menial and the magical every day. We’re serious, but never stuffy. We keep our cool under pressure because we assume best intentions and maintain perspective. This allows for true teamwork, with a dash of irreverence.
WORK BETTER TOGETHER
We are tenacious and united in our pursuit of solving our customers’ biggest challenges, and no challenge is too big. Diverse backgrounds across our team make us more effective as we listen, absorb, collaborate, and iterate to innovate.
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