Principal Quality Systems Compliance Engineer
Are you a highly skilled and driven Quality Systems Compliance Engineer looking for your next challenge? Look no further than Boston Scientific! We are seeking a Principal Quality Systems Compliance Engineer to join our team and play a critical role in ensuring compliance with regulatory standards and driving continuous improvement of our quality systems. This is a unique opportunity to make a real impact on the development and delivery of life-changing medical devices. If you have a passion for quality and a strong background in engineering, regulatory compliance, and leadership, we want to hear from you!
- Ensure compliance with all regulatory standards and requirements for the development and delivery of medical devices.
- Develop and implement quality systems processes and procedures to maintain compliance and drive continuous improvement.
- Lead and manage internal audits, as well as prepare for and support external audits and inspections.
- Monitor and analyze quality data to identify trends and areas for improvement.
- Collaborate with cross-functional teams to identify and resolve quality issues and implement corrective and preventive actions.
- Keep up-to-date with changes in regulatory requirements and communicate any potential impact to the organization.
- Train and educate team members on quality systems and regulatory compliance.
- Provide guidance and support to other engineers and team members on quality systems and compliance matters.
- Participate in the development and review of product design, manufacturing processes, and documentation to ensure compliance.
- Drive a culture of quality and continuous improvement throughout the organization.
- Act as a subject matter expert on quality systems and compliance matters.
- Lead and participate in quality related projects and initiatives.
- Represent the company during interactions with regulatory agencies.
- Develop and maintain relationships with internal and external stakeholders to ensure a collaborative and compliant approach to quality systems.
- Mentor and coach junior team members to support their professional growth and development.
Bachelor's Degree In Engineering Or A Related Field: A Strong Background In Engineering Is Essential For This Role As It Involves Overseeing Quality Systems Compliance For Medical Devices.
Minimum Of 7 Years Of Experience In Quality Systems Compliance: Candidates Should Have Extensive Experience In Quality Systems Compliance, Particularly Within The Medical Device Industry.
Knowledge Of Fda Regulations And International Standards: As A Principal Quality Systems Compliance Engineer At Boston Scientific, The Candidate Will Be Responsible For Ensuring Compliance With Fda Regulations And International Standards, So A Thorough Understanding Of These Is Important.
Strong Leadership And Project Management Skills: This Role Involves Leading And Managing A Team To Ensure Compliance With Quality Systems, So Candidates Should Have A Proven Track Record Of Successfully Managing Projects And Teams.
Excellent Communication And Problem-Solving Abilities: The Ability To Communicate Effectively With Cross-Functional Teams And To Identify And Resolve Compliance Issues Is Crucial For This Role. Candidates Should Be Able To Demonstrate Strong Problem-Solving Skills And Attention To Detail.
Quality Assurance
Process Improvement
Quality Management
Quality
Root Cause Analysis
Change control
Compliance Management
Risk assessment
DOCUMENT CONTROL
Audit management
Regulatory compliance
Supplier management
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Principal Quality Systems Compliance Engineer in Arden Hills, MN, USA is $120,000-$150,000 per year. This can vary depending on the specific company, experience level, and other factors.
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Boston Scientific Corp. engages in the development, manufacture and marketing of medical devices that are used in interventional medical specialties. Its products and technologies are used to diagnose or treat medical conditions, including heart, digestive, pulmonary, vascular, urological, women's health and chronic pain conditions.
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