Senior Quality Engineer - PMS

Tempus • Boca Raton, FL

212d • $90,000 - $130,000

About The Position

Tempus is 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.

Requirements

• 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

Nice To Haves

• 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

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

Benefits

• Incentive compensation
• Restricted stock units
• Medical and other benefits depending on the position

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees