Commercial Quality Engineer
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness.
We are searching for the best talent to join us as a Commercial Quality Engineer in Selzach, Switzerland.
Purpose:
In this role, you will be responsible for the execution of the Quality Management Systems and Compliance at our Selzach Deliver Distribution Centre. Here we receive, pick, pack, store, inspect, repack/relabel and deliver finished goods to Customers, Retailers, Wholesalers and Distributors. You will support the execution and continuous improvement of Quality Management Systems and compliance, while collaborating with Deliver Operations, Customer Service, and global quality organizations to resolve quality issues, ensure regulatory compliance, and optimize distribution quality processes.
You will be responsible for:
- Training: Establish, maintain, and oversee all training processes, assignments, materials, and training metrics, while supporting the site on training-related questions.
- Records Management: Manage and maintain the RIM (Records & Information Management) process per J&J WWRIM requirements and support compliance assessments to ensure proper identification and retention of GxP records.
- Distribution and Inventory Management Processes: Execute and oversee quality controls for distribution and inventory activities (such as receiving, pick, pack, lot reconciliation) and perform product impact evaluations and product disposition according to product-owner instructions.
- Quality Management Systems: Handle distribution-related customer complaints, ensure effective change control, and manage Quality System elements including NC/CAPA, document management, training management, risk management, and Quality Agreements.
- Internal Audit and Inspection: Participate in and support internal and external audits.
- Batch Record Verification: Support maintenance and execution of batch-verification-related processes.
- QSMR / Metrics: Contribute to preparing QSMR (Quality System Management Review) metrics, inputs, and presentations.
- Document Control: Ensure document compliance with GDP requirements, oversee creation and updates, and execute periodic document reviews on time.
- Stop Shipment / Field Action: Support the Stop Shipment process when required.
Qualifications / Requirements:
- Proven success in quality improvement initiatives, risk-reduction projects, and supply-chain value-adding solutions, with strong understanding of the linkages in quality and regulatory compliance requirements across customer delivery and health-authorities' expectations.
- Undergraduate degree in engineering, scientific, business, or QRC disciplines (or equivalent relevant industry experience).
- Solid experience in Quality & Compliance (Q&C) management, including QMS processes and compliance activities, with a strong customer and business orientation.
- Demonstrated ability to remediate issues effectively and lead or support change-management activities.
- Strong collaboration and interpersonal skills, with the ability to work effectively across diverse social, cultural, and operational environments.
- Excellent communication and presentation skills, capable of building trust, credibility, and influence across Quality, Supply Chain, and Commercial organizations.
- High accountability and a hands-on operational mindset, with the ability to lead through change, navigate constructive conflict, and operate successfully in complex organizational settings.
- Strong analytical capability and comfort managing complexity, including the ability to "zoom in and out" between detailed problem-solving and high-level strategic thinking, plus experience engaging with global regulatory agencies (such as FDA, MHRA, TGA, notified bodies).
We are looking for an individual with diverse business background, preferably with direct experience in MedTech segments, specific quality and regulatory compliance competencies in the areas of Customer Service, product handling, storage and distribution, and commercial customer interface as well as experience in positions with broadly based quality management experience. Experience with the global demands of the role in healthcare regulatory requirements is also preferred.
At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.
Here's what you can expect:
- Application review: We'll carefully review your CV to see how your skills and experience align with the role.
- Getting to know you: If there's a good match, you'll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
- Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
- Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
Finally, at the end of the process, we'll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process!