Sr. Quality Control Engineer

Job Summary

The Senior Quality Control Engineer plays a critical role in ensuring that orthopedic implants and instruments meet strict quality, safety, and regulatory requirements. This position is responsible for leading quality control processes, performing advanced inspections and statistical analyses, driving continuous improvement initiatives, and collaborating with cross-functional teams to maintain compliance with FDA, ISO 13485, and GMP regulations. The Sr. QC Engineer also mentors junior engineers and technicians while implementing best practices to enhance product reliability and manufacturing efficiency.

Responsibilities

Quality Control & Inspection:

• Develop, implement, and optimize inspection and testing procedures for Onkos orthopedic devices.

• Perform advanced dimensional analysis using CMMs (Coordinate Measuring Machines), optical comparators, micrometers, calipers, and laser measurement systems.

• Oversee first article inspections (FAI), incoming, in-process, and final product inspections.

• Apply Geometric Dimensioning & Tolerancing (GD&T) principles to evaluate component and assembly specifications. Compliance & Documentation:

• Ensure strict adherence to FDA, ISO 13485, and Good Manufacturing Practices (GMP).

• Maintain and review quality documentation, including non-conformance reports (NCRs), corrective and preventive actions (CAPAs), risk assessments, and validation reports.

• Support internal and external audits, acting as a subject matter expert on quality control processes.

• Develop and update Standard Operating Procedures (SOPs), work instructions, and quality control plans. Process Improvement & Leadership:

• Identify process inefficiencies and lead continuous improvement initiatives using Lean Six Sigma methodologies.

• Investigate product defects, perform root cause analysis (RCA), and drive CAPA implementation.

• Collaborate with manufacturing, engineering, and regulatory teams to troubleshoot quality issues and enhance product consistency.

• Mentor and train junior engineers and quality control technicians on best practices in inspection, testing, and regulatory compliance. Equipment Calibration & Maintenance:

• Oversee the calibration, validation, and maintenance of inspection and testing equipment.

• Evaluate and introduce new measurement technologies to improve quality control accuracy and efficiency. Requirements:

• Education: Bachelor’s degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or a related field (Master’s degree preferred).

• Experience: 5+ years of quality control experience in medical device, orthopedic, or precision manufacturing.

• Technical Skills:

• Expertise in GD&T, blueprint reading, and SPC methodologies.

• Advanced proficiency in CMM programming and operation.

• Strong knowledge of ISO 13485, FDA regulations, GMP, and risk management (ISO 14971).

• Experience with process validation (IQ, OQ, PQ) and Gage R&R studies.

• Proficiency in quality management systems (QMS), Minitab, and ERP software.

• Soft Skills:

• Excellent problem-solving, analytical, and critical-thinking abilities.

• Strong communication and leadership skills with the ability to influence cross-functional teams.

• Ability to manage multiple projects and work independently in a fast-paced environment.

• Certifications (Preferred): ASQ Certified Quality Engineer (CQE), Six Sigma Green/Black Belt, or equivalent.

• Work Environment: o Standing for extended periods and lifting materials up to 25 lbs may be required.

o Compliance with cleanroom and safety protocols.

o Close collaboration with engineering, production, and regulatory teams.

About Onkos

At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause.

At Onkos Surgical, we exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients.

At Onkos Surgical, we will:

• Find solutions to our patients’ unmet clinical needs and advocate for their cause.

• Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently.

• Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance.

• Fulfill our employees’ desire to make a difference in the lives of the patients they serve while achieving their own professional growth.

• Deliver value to our customers and shareholders.