QA Product Release Associate

Mission

The QA Product Release Associate plays a critical role in ensuring the delivery of safe, effective, and compliant IBA Proton Therapy products and upgrades/updates. This position is responsible for the final release of devices, verifying compliance with regulatory requirements and ensuring product quality. The Associate also conducts thorough quality reviews and approvals throughout the design and development lifecycle of IBA Proton Therapy solutions, contributing to the continuous improvement and excellence of our life-saving technologies.

Challenges we trust you with

• Approve final release of IBA Clinical products
• Ensure Quality involvement on assigned projects: participate to meetings, reply to quality related questions, …
• Review product & project documentation
• Review and approve product verification and validation activities needed for final release
• Review and approve non-conformities handling decisions including follow-up of required corrections and corrective actions
• Review and approve product design change activities
• Perform in process quality audits and ensure follow-up of resulting corrections and corrective actions
• Monitor and ensure implementation of the QMS (Quality Management System) of processes and activities reviewed as part of the release activities. Support its improvement.
• Develop, maintain and improve procedures, work instructions and templates within the area of expertise
• Train and assess training needs of IBA personnel on quality requirements related to release activities & good documentation practices

What we value

You have:

• Bachelor’s degree in scientific field such as engineering, physics, chemistry, biology
• At least 2 years of work experience in a regulated environment, in a quality role

And you also are:

• An assertive person with very good interpersonal skills
• Able to manage different projects in parallel
• Able to work to strict deadlines and to cope with pressure
• Rigorous but don’t lose the general picture
• A hands-on and proactive person, able to find and propose collaborative solutions
• A team player
• Willing to travel (up to 10%)

Preferred Qualifications

• Previous experience in manufacturing or R&D environments for medical devices
• Working knowledge of ISO13485 and/or 21CFR820
• Demonstrated knowledge of Machinery Directive, Medical Device, Regulation, ISO 9001/13485.

Compensation and Benefits

The approximate annual base salary range for this position is provided below. Within this range, individual compensation is influenced by various factors such as location, job-specific skills, work experience, and relevant education or training. This role may also qualify for discretionary bonuses, profit sharing, commissions, and benefits.

Approximate Range
$95,500 – 126,300 USD

IBA is committed to recognizing your dedication and contributions to our company's success while upholding the standards of a B Corp and living by our values. As a result, we provide benefit plans that not only reward your hard work but also offer you and your family comprehensive and affordable financial, health, and wellness protection. We are confident that you will find our benefit offerings to be of great value for both you and your dependents.

Foundational Benefits paid for 100% by IBA:
Basic Life insurance (1x annual pay)
Accidental Death & Dismemberment Insurance (1x annual pay)
Short Term Disability (80% of pay)
Long Term Disability (60% of pay)
Medical Insurance premium subsidy for each of the 3 available options
Wellness Program cash incentives (up to $500/year)
Annual contribution to Health Savings or Health Reimbursement Accounts
Dental Insurance premium subsidy
Vision Insurance premium subsidy
4% 401(k) Plan match
Profit Sharing Plan
10 weeks 100% paid Parental Leave (Mothers and Fathers)
7 personal days annually
10 days of PTO in first year
Emergency Travel Services
Employee Assistance Plan
Tuition Reimbursement Program
Professional growth education programs
Above and Beyond Reward Program
Job referral rewards

Additional benefits available:
Voluntary Life Insurance
Voluntary Spousal Life Insurance
Pre-paid Legal Services
Health Savings Account
Health Care Flexible Spending Account
Dependent Care Flexible Spending Account

Life at IBA

IBA team members thrive in a fast-paced, dynamic environment and have demonstrated exceptional results through a range of different pursuits. We all tightly align with our company values of Care, Dare, Share, and Be Fair. As we grow, we are looking to add talented people who are mission driven and bring diverse perspectives and new ways of solving problems.