Job Description
As a Senior Quality Systems Engineer, you will play a key role in ensuring the quality and integrity of our medical devices, collaborating with a diverse team of innovators to drive game-changing solutions.
At Solventum, we pioneer breakthrough innovations at the intersection of health, material, and data science, changing patients' lives for the better while enabling healthcare professionals to perform at their best.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy.
As a Senior Quality Systems Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.
Your responsibilities will include:
- Representing the Quality function in Site Management meetings as required.
- Acting as a delegate for the Quality Lead.
- Leading and implementing significant process improvements, projects, and cost-saving initiatives using data and quality tools to drive quality decisions.
- Initiating project plans, identifying resource allocations, performing, and guiding technical activities such as risk documentation, procedural updates, test methods, process/software validation that have major importance to the business.
- Leading investigations and providing technical guidance to peers in relation to Software Validation, CAPAs, and NC, and to address compliance issues and providing guidance to engineering.
- Performing and leading Internal and Supplier Audits.
- Facilitating and participating in external regulatory body audits, e.g., ISO and FDA.
To be successful in this role, you will require:
- A Bachelor's Degree or higher in Engineering or Science-related field (minimum level 8).
- Five (5) years' experience working in a regulated environment, specifically medical device, FDA, or ISO 13485 registered work environments.
- Lead Auditor or Internal Auditor certification is an advantage.
- Experience with the use of JIRA, Qtest, and VERA for documenting software lifecycle is advantageous but not essential.
- Knowledge and experience of Oracle, Factory Talk applications, PEMAC, and Bartender is advantageous.
Solventum offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
We are an equal opportunity employer and value diversity at our company.
We are committed to maintaining the highest standards of integrity and professionalism in our recruitment process.