Quality System Engineer, Principal
Olympus
- Westborough, MA
- $116,751-163,452 per year
- Permanent
- Full-time
- 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.
- BS degree or equivalent in an engineering or life science discipline. Master's Degree preferred.
- Minimum of 8 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.
- 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 applications (work, excel, PowerPoint, Project, & Visio).
- Demonstrate the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company
- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive Medical, Dental, Visions coverage effective on start date
- 24/7 Employee Assistance Program
- Free virtual live and on-demand wellness classes
- Work-life balance supportive culture with hybrid and remote roles
- 12 Paid Holidays
- Educational Assistance
- Parental Leave and Adoption Assistance
- Volunteering and charitable donation match programs
- Diversity & Inclusion Programs including Colleague Affinity Networks
- On-Site Child Daycare, Café, Fitness Center**