Quality Engineer |Astute Medical

Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests.  To support the commercialization of its novel biomarker products, including the FDA-cleared, CE-marked NephroCheck® Test for acute kidney injury, Astute Medical is seeking an energetic, experienced, and self-motivated individual for the position of Quality Engineer.

JOB SUMMARY:

Reporting to the Senior Director of Quality Assurance, this position will be responsible for working within the Quality Assurance team to ensure Astute Medical maintains compliance to applicable regulatory requirements, including those for ISO13485 & 21CFR Part 820, and establishes compliance to modified or new regulations, including those related to market expansion.  This position will be a Quality Assurance Engineering position with direct responsibility for management of Quality Assurance activities related to design, development and commercialization of Astute’s new in vitro diagnostic products.  This role will have responsibility for Quality Assurance activities related to the maintenance of existing products including market expansion. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Quality lead on Design Control teams for new product development.  Prepare and review Design Control documentation for assessment of impact to all areas of Design Control (e.g., design input requirements, verification, validation, requirement outputs, design reviews, etc).  Work with Contract Manufacturing Organizations and Materials Management for Design Transfer and Supplier Management Quality Assurance activities related to new product development.  Responsible for ensuring all DHF documentation is present, compliant and maintained.
  • Write risk reports and conduct post-market surveillance on product lines in compliance with current requirements for ISO14971.    
  • Refine Quality System procedures and processes based on knowledge of regulations and business needs as well as output from the CAPA system.  Assess quality management system for impact of new standards/regulations (e.g., IVDR) and market expansion, especially as related to Design Controls. 
  • Facilitate cross-functional team meetings for collaboration on Design Control deliverables, risk management, manufacturing change requests, and internal audit findings.
  • Responsible for investigating and documenting NCRs/CAPAs within the Quality System as well as reviewing and approving NCRs/CAPAs conducted by other departments.  Aid in the review of actions to close NCRs/CAPAs, developing and conducting effectiveness verifications, and tracking the status of NCRs/CAPAs.  Subject matter expert to define strategy, acceptance criteria and timelines with team for software validation and verification, including review and approval, in accordance with Astute Medical policies and procedures.
  • Conduct all aspects of supplier and internal audits. Develop and write audit plans, conduct audit, write audit reports.  Collaborate with audit team and auditees on findings and corrective actions.
  • Responsible for ensuring compliance with applicable Astute Medical policies and procedures across the organization.
  • Mentor members of cross-functional teams in all areas of Quality 
  • Performs other duties & projects as assigned.
  • Identifies and addresses all complexities of compliance issues

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

  • BS/BA degree (or higher) in science or technical discipline
  • 5 – 7 years relevant Quality Assurance experience.  Prior experience with new in vitro diagnostic product development, preferred.
  • Possess in-depth knowledgeable and experience of federal and other regulations, e.g. QSRs (Part 820 & Part 11), IVDR, ISO 13485.
  • Strong emphasis placed on working with technical disciplines and understanding of product and process technologies.
  • Knowledge and application of statistical techniques.
  • Ability to work independently, exercise sound judgment, manage diverse and conflicting priorities and projects in an effective manner, and meet deadlines.
  • Strong communication skills (verbal & written) including ability to interact positively with all levels of the organization.
  • Ability to work cohesively with multi-disciplinary scientific working groups.
  • Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks
  • Proficient with Microsoft Office suite.
  • Willing and able to travel as required (~10-20%)

PHYSICAL DEMANDS:

While performing the duties the employee is:

  • Constantly required to reach computers and other office and laboratory equipment
  • Constantly required to view objects at close and distant ranges
  • Frequently required to communicate with others
  • Frequently required to sit
  • Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
  • May occasionally be required to travel to meetings and audits

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

WORK ENVIRONMENT:

Employee frequently works in an office environment with a moderate amount of noise and activity.  The work environment is fast-paced and demanding.  Workweeks exceeding 40 hours are required as necessary.

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