Senior Quality Engineer - PMS

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

We are seeking a Senior Quality Engineer – PMS with a strong foundation in FDA Quality System Regulation (21 CFR 820) and ISO 13485. The ideal candidate will also bring experience with CAP/CLIA and New York State regulatory requirements, particularly in support of laboratory-developed tests (LDTs) through their development, validation, and implementation. This role will be responsible for supporting quality metric monitoring and trending, driving resolution of non-conformances and major incidents, and leading Post-Market Surveillance activities such as complaint investigations. The Senior Quality Engineer will also play a key role in supporting international product development efforts, helping to ensure compliance and quality across global markets.

RESPONSIBILITIES

• Assist in Quality Data trending and monitoring efforts within the Quality Assurance organization

• Develop high level reporting strategy and metrics to be reported in Quality Management Review to enable executive management to take action to improve process and product quality.

• Work cross-functionally to implement metric reporting in all pertinent areas of operations.

• Lead Major incident management from a quality engineering perspective, collaborating cross functionally as needed to resolve incidents and improve process and product quality.

• Support Post Market Surveillance Program by assisting in authoring procedures and establishing processes

• Work with Operations to appropriately trend control limits, exception events, and other assay quality data, as needed

• Lead quality engineering development activities on international product core teams, including risk management

• Support post market surveillance activities including complaint analyses, failure investigations, adverse event reporting, product concerns, and field action execution. 

• Work closely with complaint handling specialists in determining reportability ,and data analyst for trending and signal detection on all commercially released products.

• Assist in authoring post market plans and reports throughout the clinical/commercial lifecycle as well as the communication of post market information with functional leaders of Tempus to drive action when required. 

• Assist regulatory affairs on regulatory reporting as required submit vigilance reports to authorities, respond to requests from authorities by notified bodies and regulatory agencies. 

• Participate in CAPA investigations and root cause analysis as required.  

• Assist as backroom support in audits and inspections from regulatory agencies

Qualifications 

• Bachelor's degree or equivalent in Biology, Chemistry, or related field.

• 5+ years' experience in a medical device, IVD or pharmaceutical industry, or equivalent combination of education and experience.

• Advanced knowledge of and application of best practices in Quality Systems, Quality Engineering, Quality Assurance, Quality Management, and quality metrics/statistics reporting required.

• Proven ability to collaborate and influence with or without authority, facilitate groups with diverse perspectives and align teams.

• Multitasks, prioritizes and meets deadlines in a timely manner.

• Strong organizational and follow-up skills, as well as attention to detail.

• Solid communication and interpersonal skills, with ability to effectively communicate at multiple levels in the organization.

• Knowledge of FDA Quality System Regulation (QSR), GMP, ISO 13485:2016, ISO 14971, MDSAP and EU-IVDR is a plus.

• Experience within the area of PMS and/or IVD/MD Vigilance reporting is a plus.

• Previous experience with external/regulatory agency audits/inspections.

Illinois Pay Range: $90,000-$130,000
New York and California Pay Range: <