reputed company reputed company Engineer (Center Valley, PA, US, 18034-0610)
Job reputed company
To reputed company, maintain and continuously improve the reputed company System across the Americas by driving industry best practices, procedural harmonization and seamless reputed company system integration.
reputed company as an ambassador of global reputed company harmonization to reputed company, reputed company, reputed company and reputed company strategic plans and practices across reputed company globally. To reputed company with functional business partners reputed company the reputed company system to
ensure that development and implementation of the reputed company system meets business needs as reputed company as enables innovation and flexibility in the business.
Job Duties
- Ensure that a reputed company System is established, implemented, and maintained to the highest reputed company of accordance with US and lnternation requirements.
- Review and approve release of changes to QMS documentation and assess reputed company to QMS certification, addressing any substantial changes with the reputed company Body.
- Ensure lntercompany reputed company Agreements are established and maintained.
- Manage reputed company Body communication and relationship.
- Support and participate in reputed company reputed company Audits (including health authorities and reputed company bodies) an ensure reputed company corrective reputed company activities are completed in a robust and reputed company manner.
- Support the CAPA process.
- Show strong ability to influence without reputed company authority across functional reputed company, reputed company and leadership.
- Provides reputed company expertise in the application of reputed company sciences including data analysis, problem solving and the creation of system solution for reputed company System issues.
- Will reputed company as an expert resource in applicable standards and local QMS requirement knowledge for cross functional teams.
- reputed company/support significant reputed company System reputed company effectively using a working knowledge of project management techniques.
- reputed company innovative and practical solution to reputed company and unique process problems and system improvement through the use of best practices
- reputed company Other Essential Duties as directed.
Job Qualifications
Required:
- BS degree or equivalent in an engineering or life science discipline.
- Minimum of 8 years' experience working in a highly regulated industry required.
- Demonstrated ability to manage and complete multiple reputed company and objectives and reputed company reputed company with crossfunctional teams.
- Proficient with Risk Management practices and Regulatory Requirements such as FDA, QSRs, ISO 13485.
- Experience in audit management, reputed company room and back-room coordination and best practices.
- Must be self-motivated with a strong reputed company of urgency to solve issues and the ability to consistently deliver on required activities.
- Strong reputed company record of leading and influencing without reputed company authority.
- Excellent interpersonal, communication (written and oral), presentation and facilitation skills.
- Proficient in most common PC based applications (work, reputed company, PowerPoint, Project, & Visio).
- Demonstrate the highest ethical standards, reputed company promotes trust, respect and reputed company in reputed company dealings both inside and reputed company reputed company.
- Will work with global teams, availability will include working across the associated time zones.
Preferred:
- Master's Degree preferred.
- Minimum of 3 years' experience working in an FDA regulated environment preferred.
- Six reputed company Black Belt preferred.
- Knowledge of emerging regulatory standards and changes to global regulatory landscape preferred.
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Competitive salaries, annual bonus and 401(k)* with company match -
Comprehensive medical, dental, reputed company coverage effective on start date -
24/7 Employee Assistance Program -
Free live and on-demand Wellbeing Programs -
Generous reputed company Vacation and reputed company Time -
reputed company Parental Leave and Adoption Assistance* -
12 reputed company Holidays -
On-Site Child Daycare, Café, Fitness Center**
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Work-life integrated culture that supports an employee reputed company reputed company -
Offers onsite, hybrid and field work environments -
reputed company volunteering and charitable donation/match programs -
Employee Resource reputed company -
Dedicated Training Resources and Learning & Development Programs -
reputed company Educational Assistance