Quality System Engineer, Principal
Westborough | Permanent | www.tiptopjob.com |
Working Location:MASSACHUSETTS, WESTBOROUGH; CALIFORNIA, SAN JOSE; NATIONWIDE; PENNSYLVANIA, CENTER VALLEY; TENNESSEE, BARTLETT
Workplace Flexibility:Hybrid
Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.
Our Purpose is to make people's lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: Integrity : Empathy : Agility : Unity : Long:Term View
We deliver on our purpose and our core values by staying True to Life.
Job Description
To develop, maintain and continuously improve the Quality System across the Americas by driving industry best practices, procedural harmonization and seamless quality system integration.
Act as an ambassador of global quality harmonization to share, develop, deploy and integrate strategic plans and practices across Olympus globally. To interface with functional business partners within the quality system to ensure that development and implementation of the quality system meets business needs as well as enables innovation and flexibility in the business.
Job Duties
• Ensure that a Quality System is established, implemented, and maintained to the highest levels of accordance with US and Internation requirements.
• Review and approve release of changes to QMS documentation and assess impact to QMS certification, addressing any substantial changes with the Notified Body.
• Ensure Intercompany Quality Agreements are established and maintained.
• Manage Notified Body communication and relationship.
• Support and participate in internal and external Quality Audits (including health authorities and notified bodies) an ensure related corrective action activities are completed in a robust and timely manner.
• Support the CAPA process.
• Show strong ability to influence without direct authority across functional groups, regions and leadership.
• Provides resident expertise in the application of Quality sciences including data analysis, problem solving and the creation of system solution for Quality System issues.
• Will act as an expert resource in applicable standards and local QMS requirement knowledge for cross functional teams.
• Lead/support significant Quality System projects effectively using a working knowledge of project management techniques.
• Develop innovative and practical solution to complex and unique process problems and system improvement through the use of best practices
• All Other Essential Duties as directed.
Job Qualifications
Required:
• BS degree or equivalent in an engineering or life science discipline. Master's Degree preferred.
• Minimum of8 years' experience working in a highly regulated industry required.
• Demonstrated ability to manage and complete multiple projects and objectives and lead projects with cross:functional teams.
• Proficient with Risk Management practices and Regulatory Requirements such as FDA, QSRs, ISO 13485.
• Experience in audit management, front room and back:room coordination and best practices.
• Will work with global teams, availability will include working across the associated time zones.
Preferred:
• Minimum of 3 years' experience working in an FDA regulated environment preferred.
• Six Sigma Black Belt preferred.
• Knowledge of emerging regulatory standards and changes to global regulatory landscape preferred.
• Must be self:motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities.
• Strong track record of leading and influencing without direct authority.
• Excellent interpersonal, communication (written and oral), presentation and facilitation skills.
• Proficient in most common PC based appli
Workplace Flexibility:Hybrid
Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.
Our Purpose is to make people's lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: Integrity : Empathy : Agility : Unity : Long:Term View
We deliver on our purpose and our core values by staying True to Life.
Job Description
To develop, maintain and continuously improve the Quality System across the Americas by driving industry best practices, procedural harmonization and seamless quality system integration.
Act as an ambassador of global quality harmonization to share, develop, deploy and integrate strategic plans and practices across Olympus globally. To interface with functional business partners within the quality system to ensure that development and implementation of the quality system meets business needs as well as enables innovation and flexibility in the business.
Job Duties
• Ensure that a Quality System is established, implemented, and maintained to the highest levels of accordance with US and Internation requirements.
• Review and approve release of changes to QMS documentation and assess impact to QMS certification, addressing any substantial changes with the Notified Body.
• Ensure Intercompany Quality Agreements are established and maintained.
• Manage Notified Body communication and relationship.
• Support and participate in internal and external Quality Audits (including health authorities and notified bodies) an ensure related corrective action activities are completed in a robust and timely manner.
• Support the CAPA process.
• Show strong ability to influence without direct authority across functional groups, regions and leadership.
• Provides resident expertise in the application of Quality sciences including data analysis, problem solving and the creation of system solution for Quality System issues.
• Will act as an expert resource in applicable standards and local QMS requirement knowledge for cross functional teams.
• Lead/support significant Quality System projects effectively using a working knowledge of project management techniques.
• Develop innovative and practical solution to complex and unique process problems and system improvement through the use of best practices
• All Other Essential Duties as directed.
Job Qualifications
Required:
• BS degree or equivalent in an engineering or life science discipline. Master's Degree preferred.
• Minimum of8 years' experience working in a highly regulated industry required.
• Demonstrated ability to manage and complete multiple projects and objectives and lead projects with cross:functional teams.
• Proficient with Risk Management practices and Regulatory Requirements such as FDA, QSRs, ISO 13485.
• Experience in audit management, front room and back:room coordination and best practices.
• Will work with global teams, availability will include working across the associated time zones.
Preferred:
• Minimum of 3 years' experience working in an FDA regulated environment preferred.
• Six Sigma Black Belt preferred.
• Knowledge of emerging regulatory standards and changes to global regulatory landscape preferred.
• Must be self:motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities.
• Strong track record of leading and influencing without direct authority.
• Excellent interpersonal, communication (written and oral), presentation and facilitation skills.
• Proficient in most common PC based appli
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