Halifax-based biotech company Adaptiiv Medical Technologies continues to grow and is hiring a Quality Manager, a posting that headlines our Jobs of the Week column.
Adaptiiv, which raised $3.4 million in equity financing earlier this year, has developed a system that 3D prints a bolus – a piece of plastic that is placed over the cancerous area in a patient undergoing radiation therapy. The radiation hits the bolus, builds up and then is transferred into the tumour.
Hospitals using the Adaptiiv product buy a system that includes 3D printers with special filaments, so boluses customized to each patient can be printed within seconds.
The Jobs of the Week column features openings posted on the Entrevestor Job Board, which focuses on jobs in technology, innovation and startups in Atlantic Canada. The Entrevestor Job Board helps match job openings and candidates in the tech and startup communities and is operated by Entrevestor and Alongside.
Here is an excerpt from the headline posting this week:
Adaptiiv Medical Technologies
We are looking for an individual to help manage our quality management system and regulatory affairs fillings!
Reporting to the Senior Manager, Finance and Operations, the Quality Manager will act as the Quality Management Representative with authority to ensure the quality management systems' requirements are effective and maintained in accordance with ISO standard, FDA, CE, EU, & Australian regulations.
This position plays a significant role in overseeing and improving quality standards, directives, and policies for Adaptiiv. The role requires experience working in a fast-growing organization, with a proven track record of successful leadership capabilities, directing day to day activities with regulatory liaisons, and providing ongoing coaching to develop the skills of the other employees
Support the Adaptiiv team by helping to enhance and/or harmonize the Quality System
Partners and collaborates with the Director to ensure customer requirements are met and quality measures and compliance strictly adhered to.
Provide a strong voice and direction for the Operations and Quality group
AUDITS: Lead (or direct) the internal audits and collaborate internally to execute routine, risk based monitoring and auditing of relevant internal activities to applicable regulations, guidelines, policies and procedures; identify potential areas of compliance vulnerability and risk; oversee the implementation of corrective action plans as necessary; and generate reports on monitoring, auditing and risk assessment for the business; Lead external audits including customer, and supplier audits to ensue execution of the annual audit plan.
Ensure all audit observations are communicated, analyzed, and remediated in compliance with internal policies and applicable regulatory requirements.
Direct all aspects of the internal non-conformance management systems, specifically CAPA, deviations, risk assessments, Supplier Corrective Actions Reports (SCARS) and Plans or Supplier Questionnaires.
Evaluate and challenge the quality system and practices within the site to continuously improve the efficiency of those systems and their levels of compliance.
Recommend and implement corrective actions to support continuous improvement programs. · Support and oversee all QA Documentation ensuring related procedures reflect current practice clearly and accurately.
Support new product development, which includes oversight (but not ownership) of the design control process in partnership with development teams
Review controlled documents such as quality manual, quality policies, standards and regulations per the periodic document review requirement.
Lead and manage regulatory filings for commercial product release (510K, CE Mark) . . . .