Investigation Sr. Specialist

bioMérieux; Hazelwood (MO); On-site; USD 84,000 - 126,000; Full time

Benefits offered by this job

Medical and dental plans

Retirement plan with employer ̶-contri

Wellness programs

Commuter benefits

Parental leave

Job summary

bioMérieux in Missouri is seeking an Investigation Senior Specialist to lead post-market quality investigations, analyze product performance data, and identify trends that could affect quality, reliability or compliance. You will collaborate cross-functionally to assess risk and support CAPA and regulatory requirements.

You'll prepare findings, support audits, develop SOPs, and drive continuous improvement across Quality, Regulatory, Manufacturing, R&D and Technical Support teams in a

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, Biomedical Sciences, Biotechnology, Engineering, or Medical Laboratory Science related degree required.
• 5+ years of experience with complaint handling, investigations, post-market surveillance, quality systems, or risk management in a Quality, Regulatory, Manufacturing, Medical Device, IVD, Life Sciences, or a related regulated industry required.
• Medical Device and/or In Vitro Diagnostics (IVD) industry experience strongly preferred.

Responsibilities

• Conduct investigations of product complaints, adverse events, and quality issues to determine root causes and recommend appropriate actions.
• Analyze complaint, service, QC, manufacturing, and field performance data to identify trends and emerging risks.
• Monitor and maintain surveillance dashboards and reliability metrics to support post-market monitoring activities.
• Perform risk assessments and provide recommendations for product quality improvements.
• Support CAPA activities, effectiveness checks, and continuous improvement initiatives.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, R&D, Technical Support, and other cross-functional teams to resolve quality concerns.
• Prepare and present investigation findings, trend reports, and recommendations to internal stakeholders.
• Support internal and external audits, inspections, and regulatory inquiries.

Skills

Analytical thinking

Communication skills

Problem solving

Detail orientation

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences, Biology, Chemistry, Biomedical Sciences, Biotechnology, Engineering, or Medical Laboratory Science related degree

Tools

Microsoft Office

Job description

The Investigation Senior Specialist supports post-market quality activities by conducting investigations, evaluating product performance data, and identifying trends that may impact product quality, reliability, or compliance. This role collaborates cross-functionally to assess product risks, support corrective and preventive actions (CAPA), and ensure compliance with applicable regulatory requirements and quality system standards.

Primary Responsibilities

• Conduct investigations of product complaints, adverse events, and quality issues to determine root causes and recommend appropriate actions.
• Analyze complaint, service, QC, manufacturing, and field performance data to identify trends and emerging risks.
• Monitor and maintain surveillance dashboards and reliability metrics to support post-market monitoring activities.
• Perform risk assessments and provide recommendations for product quality improvements.
• Support CAPA activities, effectiveness checks, and continuous improvement initiatives.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, R&D, Technical Support, and other cross-functional teams to resolve quality concerns.
• Prepare and present investigation findings, trend reports, and recommendations to internal stakeholders.
• Support internal and external audits, inspections, and regulatory inquiries.
• Develop and maintain standard operating procedures (SOPs), work instructions, and related documentation.
• Represent Post-Market Quality on cross-functional projects as assigned.
• Perform other duties as assigned.

Qualifications

Minimum Required Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, Biomedical Sciences, Biotechnology, Engineering, or Medical Laboratory Science related degree required.
• 5+ years of experience with complaint handling, investigations, post-market surveillance, quality systems, or risk management in a Quality, Regulatory, Manufacturing, Medical Device, IVD, Life Sciences, or a related regulated industry required.

Preferred Qualifications

• Medical Device and/or In Vitro Diagnostics (IVD) industry experience strongly preferred.
• Strong analytical and critical-thinking skills.
• Excellent written and verbal communication skills.
• Ability to interpret and analyze complex technical and quality data.
• Demonstrated problem-solving and root-cause investigation capabilities.
• Strong attention to detail and organizational skills.
• Ability to work effectively in a cross-functional environment.
• Proficiency with Microsoft Office applications.
• Knowledge of quality and regulatory requirements applicable to medical devices and IVD products, including FDA and ISO standards.
• Continuous improvement mindset with the ability to drive process enhancements.

Working Conditions

• Primarily office-based with periodic work in manufacturing, laboratory, or operational areas.
• Ability to sit, stand, and move throughout facility locations as needed.
• Occasional domestic and international travel may be required.
• Ability to lift and move light materials as required by the position.

Position Summary

The Investigation Senior Specialist supports post-market quality activities by conducting investigations, evaluating product performance data, and identifying trends that may impact product quality, reliability, or compliance. This role collaborates cross-functionally to assess product risks, support corrective and preventive actions (CAPA), and ensure compliance with applicable regulatory requirements and quality system standards.

Primary Responsibilities

• Conduct investigations of product complaints, adverse events, and quality issues to determine root causes and recommend appropriate actions.
• Analyze complaint, service, QC, manufacturing, and field performance data to identify trends and emerging risks.
• Monitor and maintain surveillance dashboards and reliability metrics to support post-market monitoring activities.
• Perform risk assessments and provide recommendations for product quality improvements.
• Support CAPA activities, effectiveness checks, and continuous improvement initiatives.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, R&D, Technical Support, and other cross-functional teams to resolve quality concerns.
• Prepare and present investigation findings, trend reports, and recommendations to internal stakeholders.
• Support internal and external audits, inspections, and regulatory inquiries.
• Develop and maintain standard operating procedures (SOPs), work instructions, and related documentation.
• Represent Post-Market Quality on cross-functional projects as assigned.
• Perform other duties as assigned.

Qualifications

Minimum Required Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, Biomedical Sciences, Biotechnology, Engineering, or Medical Laboratory Science related degree required.
• 5+ years of experience with complaint handling, investigations, post-market surveillance, quality systems, or risk management in a Quality, Regulatory, Manufacturing, Medical Device, IVD, Life Sciences, or a related regulated industry required.

Preferred Qualifications

• Medical Device and/or In Vitro Diagnostics (IVD) industry experience strongly preferred.

Knowledge, Skills & Competencies

• Strong analytical and critical-thinking skills.
• Excellent written and verbal communication skills.
• Ability to interpret and analyze complex technical and quality data.
• Demonstrated problem-solving and root-cause investigation capabilities.
• Strong attention to detail and organizational skills.
• Ability to work effectively in a cross-functional environment.
• Proficiency with Microsoft Office applications.
• Knowledge of quality and regulatory requirements applicable to medical devices and IVD products, including FDA and ISO standards.
• Continuous improvement mindset with the ability to drive process enhancements.

Working Conditions

• Primarily office-based with periodic work in manufacturing, laboratory, or operational areas.
• Ability to sit, stand, and move throughout facility locations as needed.
• Occasional domestic and international travel may be required.
• Ability to lift and move light materials as required by the position.

The estimated salary range for this role in the state of Missouri is between $84,300-$126,400. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMérieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.In addition, bioMérieux offers a competitive Total Rewards package that may include:

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match.
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves#biojobs