Sr Quality Systems Engineer

About the role

A Senior Quality Systems Engineer in the Acute Care & Monitoring division will play a key role in ensuring the quality and safety of medical devices. This role involves managing and driving the Corrective and Preventive Action (CAPA) Program, facilitating the application of the Quality Management System, and supporting internal and external audits and inspections.

Responsibilities

• Manage and drive the CAPA Program
• Facilitate the application of the Quality Management System
• Support internal and external audits and inspections
• Investigate and resolve compliance problems, questions, or complaints
• Provide technical expertise and guidance in interpreting policies, regulatory, and governmental regulations
• Provide oversight into the development and maintenance of quality programs, systems, processes, and procedures

Requirements

• Level 8 degree or Master's degree with 4 years of relevant experience
• Experience in the Medical Device Industry or a similar industry role
• CAPA ownership/execution experience, required
• Strong understanding of medical device regulatory and governmental regulations (EU MDR, FDA, MDSAP, ISO 13485, etc.)
• Experience in Risk Management ISO 14971 Medical Device Auditing
• Project Management experience
• Strong analytical and problem-solving skills, excellent communication skills, excellent writing and editing skills, and computer skills in the English language
• Ability to work effectively independently, within teams, and across functions
• Ability to travel on occasion

Qualifications

• U.S. work authorization
• Physical Job Requirements: Independent mobility, interacting with a computer, communicating with peers and co-workers

Skills

• Strong analytical and problem-solving skills
• Excellent communication skills
• Excellent writing and editing skills
• Computer skills in the English language
• Ability to work independently and within teams
• Ability to travel on occasion

Benefits

• Competitive Salary
• Flexible Benefits Package
• Health, Dental, and Vision Insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life Insurance
• Long-term Disability Leave
• Dependent Daycare Spending Account
• Tuition Assistance/Reimbursement
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Pay

$98,400.00 - $147,600.00 USD

Schedule

Full-time, On-site presence 4 days a week in Lafayette, CO