Manager of Quality Systems

Who we are:

Oncocyte is a precision diagnostics company. The Company's tests are designed to help provide clarity and confidence to physicians and their patients.

Mission of the role:

The Manager of Quality Systems oversees the Quality System and is responsible for establishing and maintaining a robust quality program to effectively support Oncocyte's ongoing quality processes work toward 21 CFR 820, ISO 13485 and EU IVDR compliance.

The Manager of Quality Systems reports to the head of Quality and Regulatory. The key duties include quality system development and maintenance. This may include all areas of the Quality System. Additional key duties include representation of QA on risk management teams, review and approval of documents for Quality, scheduling and/or performance of supplier audits, management of Notified Body and regulatory authority audits, A track record of learning new processes, taking on varying tasks/projects, and impeccable attention to detail is essential for this role.

The Manager of Quality Systems works with the Regulatory team to support related compliance (including leading and trending CAPAs, NCMRs, etc), continuously improve the quality management system (QMS) and assist in the preparation of necessary documents for submission of IVD products for US FDA and/or CE marking.

Your day-to-day:

• Prior to ISO 13485 certification, create QMS documents and manage the creation of QMS documents by instructing and leading other department system owners.
• Review and approve Quality System documents including but not limited to, procedures, work instructions, investigations, complaints, CAPAs, NCMRs, qualification protocols, and test reports.
• Serve as a liaison between departments to ensure alignment with quality goals and provide SME guidance and support for stakeholders, including product Legal Manufacturer R&D and Product Support teams, Commercial Operations Technical Support teams, Manufacturing operations, QA Operations and Regulatory.
• Promote awareness of applicable regulatory requirements, including QMS requirements and customer requirements throughout the organization.
• Lead CAPA and NCMR meetings, investigate CAPAs, guide Oncocyte team members in CAPA practices, and report status of CAPAs and NCMRs on a regular basis.
• Assist the regulatory and R&D teams on product submission reports.
• Coordinate or manage the quality review of supplier qualifications and approval processes, including performance of external audits when necessary.
• Manage supplier-related quality issues and coordinate resolutions.
• Oversee the quality for manufacturing functions at all sites.
• Lead complaint handling investigations in order to achieve timely resolution
• Lead activities related to internal audits and inspection readiness.
• Ensure that all established and appropriate process controls, procedures, and written work instructions are adopted and/or prepared particularly where their absence would affect quality.
• Track and report key quality metrics (KPIs) as well as patterns, trends, and other quantifiable measurements related to QMS effectiveness and product quality.
• Lead or contribute to cross-functional teams in the execution of continuous improvement projects to drive efficiencies and improve quality.
• Mentor/coach team members across the organization in quality practices.
• Assist in establishment of standards for the acceptance of testing data by devising evaluation tests, methods, and procedures.
• Ensure quality and reliability standards are met by studying product and consumer requirements with other members of management and with laboratory operators, technicians, and scientists.
• Review project plans for quality requirements prior to launch.
• Collaborate with technical staff to develop risk management documentation.
• Conduct risk management related to quality events
• Collaborate on software requirements/specifications and provide quality feedback.
• Other tasks as assigned.

What it takes to do this job:

• Bachelor's degree or equivalent in a scientific, technical, or engineering discipline.
• 7+ years' experience working in a regulated industry (i.e., medical device, laboratory, pharma and/or biotech) and experience with risk management regulations and standards, including FDA 21 CFR 820, IVDR, ISO 13485, ISO 14971.
• Knowledge and demonstrated experience with IVDs is preferred.
• Experience working in a global organization and/or interfacing with multiple locations a plus.
• Experience in performing system risk assessments and reviewing dFMEAs.
• Working knowledge of hosting and managing regulatory audits is preferred.
• Change management and facilitation skills.
• Knowledge of quality concepts and tools.
• Ability to provide technical expertise on quality topics related to IVD design, development and manufacturing.
• Demonstrated ability to work in a dynamic, collaborative environment.
• Strong written and oral communication skills, including an ability to articulate ideas clearly and appropriately influence others.
• Well-versed in project management skills.
• Ability to thrive in a demanding, change-oriented, fast paced environment requiring a high degree of deadline-driven productivity.
• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
• Exceptional ability to work autonomously within a distributed team setting in a dynamic work environment that often requires management/completion of multiple concurrent tasks within close deadlines and high demands, with a high degree of accuracy and detail.
• Creative and analytical thinker with strong problem-solving skills.
• Ability to work independently and manage multiple tasks while meeting deadlines.
• Willingness to demonstrate Oncocyte's values by acting with integrity, respect, trust and possess a very positive attitude and an understanding of the dynamics involved with organizational growth and change.

Who you are:

• You have a "do what it takes - no job is too small" team player and positive attitude with a willingness to wear other hats and step in to perform and support other roles when needed.
• You have superb written and verbal skills and an exceptional ability to communicate clearly and professionally.
• Your organizational skills, attention to detail, and ability to multi-task are excellent.
• You exhibit ethical and professional behavior at all times.
• You like building effective internal and partner relationships including with team members, clients, vendors, suppliers, and team members.

You will have the opportunity to:

• Improve patient outcomes.
• Meaningfully impact the company's short-term and long-term success.
• Work collaboratively across all levels within the organization.
• Grow your role as you see fit.
• Learn everything there is to know about cancer diagnostic laboratories.
• Create an inspiring workplace.