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Come join one of our quickly growing portfolio companies, Home - Perosphere Technologies!
Perosphere Technologies is hiring a Director of Quality to join the team based in Danbury, CT! This will be an onsite role, 5 days a week.
About Perosphere Technologies
Perosphere Technologies is changing the way decisions are made for patients at risk for bleeding. A private medical technologies company, Perosphere is focused on development and commercialization of the novel PoC (point-of-care) Coagulometer, which informs diagnosis, treatment, and prevention through precision data, made immediately accessible to all. It is the only point-of-care (POC) diagnostic tool that effectively and swiftly tests clotting times across drug classes, including Direct Oral Anticoagulants (DOACs). The fast diagnosis and related appropriate treatment decisions the PoC Coagulometer enables will help establish a new standard of care in hospital emergency departments for patients at risk for bleeding and has the potential to improve efficiency, provide significant cost savings, and better patient outcomes.
Perosphere Technologies is funded by Advantage Capital Partners, Ambit Health Ventures, Connecticut Innovations, Ogden, and others, and has been awarded multiple federal grants from the National Institutes of Health (NIH).
Why Work at Perosphere Technologies?
- 1 out of 3 DOAC Patient Admissions are incorrectly diagnosed and treated
- Perosphere’s Coagulometer (ClotChek) is the only PoC device that can test coagulation in patients on DOACs
- ~$1 billion market opportunity across Emergency Department, DOAC Outpatient, and Heparin Inpatient segments
- $1 billion in cost reduction to hospitals and payers in the US, with improved standard of care
- Coagulometer readers and cuvettes manufactured under cGMP, ready for commercial production with launch in Europe in 2024 and U.S. to follow
- Company has doubled its employees in the last 15 months, with more planned hiring in 2024 and 2025
Director of Quality
The Director of Quality Assurance is responsible for ensuring the execution of quality management system (QMS) procedures, policies and activities throughout all aspects of the organization to ensure compliance and achievement of the company strategic plan. In addition, this individual works collaboratively with PTI technical teams (internal and external) to coordinate and facilitate appropriate technical documentation files and technical dossier to support US FDA regulatory submissions and Global regulatory registrations, in targeted markets.
This role is responsible for the hands-on management of the QMS encompassing Design Control, Document Control, Records Management, Change Control, Corrective and Preventative Action, non-conformance management, Supplier Management, and oversight of the company training programs related to the QMS. The incumbent will drive, promote, and embed a culture of integrity and a proactive policy of “quality in everything we do” at PTI.
The incumbent will provide guidance and leadership to ensure that the QMS is maintained current with global standards related to the FDA and Outside US (OUS) regulatory requirements as stated in the relevant quality system documents of the FDA Code of Federal Regulations and EU In Vitro Device (IVD) Directive and IVD Regulations (IVDR), ISO and CE Mark requirements
- Act as the Quality Management System subject matter expert for all matters governed by related internal procedures, applicable regulations, standards, and guidelines.
- Act as the company Quality Management Representative as appointed.
- Lead the Risk Management process as the Risk Manager.
- Lead the implementation of QMS framework as required by internal procedures and applicable regulatory requirements.
- Maintain the internal and external audit programs.
- Provide review and approval of all product labeling.
- Provides on-site quality surveillance of all operations procedures to ensure compliance in manufacturing, product procurement and product delivery to customers.
- Establish and manage the performance and effectiveness of document control, CAPA, change control, training, product complaint, investigations, and non- conformance programs.
- Serve as the Perosphere Technologies Quality process owner for Change Management, Supplier Management, Customer Complaints, Quality Management Reviews.
- Serves as the primary on-site triage for review of all reported product issues and customer complaints.
- Serve as the Program Lead for “Management Quality Review” ensuring regular dissemination of quality status and metrics to the executive management team.
- Provided leadership in a proactive QMS continuous improvement program in support of business needs aligned with global regulations and international standards.
- Provide leadership to the technical team in the assembly of status and trending oft quality metrics for Management Quality Reviews.
- Provide the key quality interface for audits and inspections from regulatory authority inspections, internal audits and external partners.
- Represent Quality Affairs on project teams as needed, or assign other quality staff as appropriate..
- Travel as necessary to fulfill quality obligations related to auditing and compliance.
Qualifications
- Bachelors or advanced degree in a scientific, engineering or related field.
- Minimum 5 years of experience in medical device industry, preferably with in vitro diagnostics and with quality and compliance responsibility.
- Experience in implementing and managing Quality Management Systems.
- Extensive knowledge of Quality Management System; experience in implementing and managing quality systems in the medical device industry.
- Strong knowledge of FDA and international regulations and practices.
- Excellent verbal and written communication skills.
- Collaborative, analytical & interpretative skills.
- Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others.
- Previous experience in successfully leading assigned activities within cross- functional teams.
- Collaborative, analytical, and interpretative skills.
- Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others. Prior management experience is required.
Perosphere Technologies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
