RQM+ is
The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.We don’t make MedTech. We make MedTech happen.Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success.
RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparencyThe Senior Packaging Engineer supports and leads projects that positively impact the operation on the manufacturing site. Authors and execute process validation protocols for packaging equipment and processes. Is responsible for process development, process validation, and the daily support of various packaging manufacturing lines in operations.
Collaborates with cross functional groups including Quality, R&D, Regulatory, Packaging, Labeling, and Sourcing to provide leading edge packaging solutions in support of operations and Operating Unit strategic goals.The Senior Engineer ensures long term manufacturing efficiency, quality, and regulatory compliance.
Responsibilities:
- Develop packaging solutions (manufacturing processes) to complex projects in a multidisciplinary and collaborative environment as part of engineering programs.
- Authors and execute process validations for packaging equipment and processes, including tray sealing, bar sealing, form/fill/seal, band sealing equipment.
- Leads and supports process validations IQ/OQ/PQ activities for new and existing packaging equipment.
- Responsible for process development of sterile barrier system manufacturing process.
- Develop and update manufacturing work instructions and procedures for packaging processes.
- Supports manufacturing operations of various packaging lines
- Optimize existing lines through time studies, line balance, and process optimization that ensures efficient operation and compliance with all quality requirements
- Support quality investigations for quality holds, nonconformances, or field complaints.
- Support quality audits and regulatory affairs technical file submissions.
- Perform testing in a laboratory environment as per industry standards.
- Collaborates with Package and Labeling development groups for various projects.
- Supports multiple projects and collaborates with cross functional global teams to effectively complete tasks on schedule.
- Develop reports and updates for management.
Requirements:
- Bachelor’s degree required with 4+ years of operations and packaging design and process validation experience, or advanced degree with 2+ years’ experience
- Experience in medical product manufacturing / assembly operations techniques and practices
- Knowledge in Lean Manufacturing / Six Sigma methodologies (A3, DMAIC training)
- Project management skills
- Strong written and verbal communication skills
- Aptitude for quickly learning and simulating a broad array of information
- Experience with line layout, line balancing, and ergonomic analysis
- Excellent data analysis skills, and proficient in the use of statistical tools in problem solving
- Preference to know and understand the whole business
Working Conditions:
- Standard office setting
- Clean room manufacturing area
- While performing the duties of this job, the employee may be regularly required to work near moving mechanical parts.
Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.
Job Opportunity Verification
At RQM+, we prioritize the security of our job applicants. To ensure a safe application process: All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careersEvery candidate going through the interview process will participate in a voice and/or video interview.Exercise caution with unsolicited job offers or requests for sensitive information.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses.
These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.Apply for this job
