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: $100,000-$150,000

The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.