At Onkos Surgical, we believe individuals with cancer and other complex orthopaedic conditions requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause.
We are an early-stage specialty medtech company based out of Parsippany, NJ that is focused on developing solutions for oncologic and other complex orthopaedic conditions in the areas of limb reconstruction, patient-specific, and advanced revision applications. We are a rapidly growing, talented team with a passion for making a difference in the lives of the patients whom we touch. We recognize that these complex, and often severe conditions, can be life changing and we operate with that in mind in all of our roles.
The Quality Control Engineering Specialist is directly responsible for supporting the Onkos Supply Chain including internal and external manufacturing, cleaning, and packaging. Direct responsibilities will include developing inspection plans for sourced and/or manufactured products, data collection, trending, and risk mitigation. Additionally, this role will be instrumental in supporting the technological platforms required in Quality Control including, Optical Comparators, Coordinate Measurement Machines, Functional Gaging, Air Gaging Profilometers and most importantly, quality control technician training. Lastly, the Quality Control Engineering Specialist will collaborate with team members in process improvements, kaizen initiatives and reducing the cost of poor quality.
- Developing and implementing quality inspection plans.
- Developing and implementing quality control systems.
- Monitoring and analyzing quality performance of internal and external supply chain.
- Validation of key inspection equipment including IQ, OQ and PQ.
- Inspecting and testing materials, processes, and products to ensure quality specifications are met.
- ISO Class #8 cleanroom compliance requirements.
- Collaborating with team members to develop and implement improvements to reduce the cost of poor quality.
- Quality data management, trending and KPI reporting.
- Risk mitigation and counter measures.
- Ensuring that workflows, processes, and products comply with quality and safety regulations.
- Investigating and troubleshooting product or production issues.
- Developing corrective actions, solutions, and improvements.
- Bachelor’s Degree in mechanical engineering, biomedical engineering or equivalent.
- ASQ certification preferred.
- 5+ years of experience in quality engineering, quality assurance, or a similar role.
- Experience with Comparators, Coordinate Measurement Machines, Gaging, Data Collection and Key Performance Indicator reporting.
- Strong communication and interpersonal skills.
- Strong analytical, organizational and problem-solving skills.
- Excellent project management skills.
- Must excel in a fast-paced environment.
- Adhere to Onkos Core Beliefs, Code of Business Conduct, all regulatory requirements, and quality standards.
- Support company advocacy initiatives to help raise awareness of sarcoma and pediatric cancer and drive positive change that will impact the lives of cancer patients.
- Travel up to 10%.
- (American Society For Quality) Asq Certified
- Biomedical Engineering
- Business Process Improvement
- Continuous Quality Improvement (Cqi)