Sr. Quality Engineer

Begell House Inc.; Cranberry Township, Northern (Butler County, KY); Hybrid; USD 80,000 - 115,000; Full time

Job summary

Omnicell is seeking a qualified professional to lead quality and change control activities in a regulated medical device environment. You will drive defect management, post-market changes, and cross-functional collaboration to ensure safe, compliant product design and lifecycle management.

Responsibilities include MDR coordination, risk assessments, CAPAs, and continuous improvement initiatives. A Bachelor’s in engineering/science and 5+ years in related roles are required, with travel up to 25%

Qualifications

• Bachelor's degree in Engineering or Science required.
• 5+ years in Engineering, Quality or related technical experience.
• Experience in product development and/or maintenance.
• Experience in process development.
• Experience in regulated environments (ISO 9001, ISO 13485 or FDA QMSR).

Responsibilities

• Lead defect management and engineering escalation processes with timely identification and reporting.
• Drive review and approval of design and verification protocols for product changes.
• Manage cross-functional teams in product change control with documented modifications.
• Maintain and update the Device Master Record (DMR) during post-market changes.
• Ensure design outputs align with inputs and comply with internal protocols.
• Act as liaison between engineering, product management, and quality teams.

Skills

QMS knowledge

Root cause analysis

Quality tools

SPC / Six Sigma

SDLC understanding

Leadership

Project management

Communication

Education

Bachelor's degree in Engineering or Science

5+ years in Engineering, Quality or related technical experience

Experience in product development/maintenance

Experience in process development

Regulated environment (ISO 9001, ISO 13485 or FDA QMSR)

Tools

Jira

Job description

Responsibilities

Change Control and Design

• Lead the execution of defect management and engineering escalation processes, ensuring timely identification, resolution, and reporting of product issues.
• Drive the review and approval of design and service verification and validation protocols, with a focus on product changes and lifecycle processes.
• Manage cross-functional teams in product change control processes and ensure comprehensive documentation of product modifications.
• Take ownership of maintaining and updating the Device Master Record (DMR) for assigned product lines during post-market changes.
• Ensure alignment of design outputs with inputs, proactively addressing discrepancies and ensuring compliance with internal protocols.
• Act as the lead liaison between engineering, product management, and quality teams to integrate quality considerations early in the product design phase.

Field, Customer and Safety

• Independently process and triage out-of-box quality issues, conducting root cause analyses and collaborating with teams to drive corrective actions.
• Lead post-production safety risk assessments and implement solutions to mitigate safety concerns.
• Drive the Medical Device Reporting (MDR) process, coordinating with regulatory bodies and managing field actions and recalls.
• Present safety and risk management updates during Safety Risk Management Board Meetings, with responsibility for product-specific risks.

Compliance and Continuous Improvement

• Lead quality improvement projects aimed at optimizing processes, reducing defects, and enhancing customer satisfaction.
• Ensure adherence to ISO 9001, ISO 13485, and other relevant regulatory standards, acting as a subject matter expert for compliance.
• Implement and analyze quality metrics, creating reports to monitor process performance and drive data-driven improvements.
• Conduct internal audits and manage corrective and preventive actions (CAPA) to ensure continued compliance and improvement.

Required Knowledge and Skills

• Advanced knowledge of QMS (Quality Management System) documentation and regulatory standards (ISO 9001, ISO 13485).
• Proficiency in quality investigation tools (e.g., Fishbone diagrams, 5 Whys) and statistical analysis (e.g., SPC, Six Sigma).
• Understanding of software development lifecycle (SDLC) and experience in defect tracking platforms like Jira
• Experience in leading cross-functional teams and managing product changes from initiation through post-market stages.
• Strong project management skills and the ability to manage multiple priorities effectively.
• Excellent problem-solving, communication, and leadership abilities.

Basic Qualifications

• Bachelor's degree in Engineering or Science discipline
• 5+ years in Engineering, Quality or related technical professional experience
• Experience in product development and/or maintenance
• Experience in process development
• Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA QMSR)

Preferred Qualifications

• Experience working with complex electro-mechanical systems
• Experience working with Cloud software and AI/ML

Work Conditions

• Office Environment
• May travel up to 25%

Drug Screen: Required

Base Compensation: $80,000.00 to $115,000.00

(Actual compensation is subject to variation due to such factors as location, education, experience, and skillset. We offer a comprehensive benefits package, including medical, dental and vision plans covering eligible US employees and dependents, voluntary wellness and employee assistance programs, life insurance, disability, retirement plans with matching, and paid time off.)

EEO, Privacy, and Adaptability

Omnicell welcomes applications from all individuals, valuing a wide range of perspectives and backgrounds. As an equal opportunity employer, we do not discriminate based on race, gender, religion, sexual orientation, gender identity, national origin, veteran status, or disability. We are committed to making our recruitment process accessible to everyone. We offer support and reasonable adjustments for individuals with disabilities during our hiring process. If you need assistance, please contact us at [e-mail].

At Omnicell, respect for privacy and confidentiality is paramount. We adhere to strict policies to prevent discrimination or retaliation against those who engage in open conversations about compensation. However, employees privy to compensation information as part of their job role are expected to maintain confidentiality, except in specific circumstances outlined by law, such as during formal complaints, investigations, or as required by legal obligations. Learn more about our privacy practices: Privacy | Omnicell

Please note that Omnicell reserves the right to modify job roles and responsibilities as needed to meet our organization’s evolving needs and drive our mission forward.