Quality Assurance Process Control Engineer

Job Summary

The QA Process Control Engineer is responsible for ensuring that all sterilization processes and microbiological testing meet the highest regulatory and quality standards. This role involves managing sterilization cycle validations, maintenance, and evaluations, overseeing product release procedures related to cleaning and sterilization.

Responsibilities

Regulatory & Quality Compliance:

• Ensure full adherence to all applicable regulatory and quality system requirements related to the cleaning and sterilization of Onkos product.
• Regularly review and update documentation and procedures to align with FDA-QSR, ISO, AAMI, and other relevant guidelines.

Sterilization Controls:

• Oversee routine sterilization validations, cycle maintenance, and cycle evaluations to guarantee product sterility and regulatory compliance.
• Critically analyze processes regarding sterilization controls, environmental monitoring programs, and product disposition.
• Evaluate proposed process changes and assess their impact on current sterilization controls.
• Oversee the timely execution and documentation of quarterly dose audits.

New Product Initiation & Validation:

• Work with Product Development in validating and adopting cleaning protocols and sterilization processes for product launches.
• Collaborate with cross-functional teams to ensure that new products meet rigorous cleaning and sterilization standards while integrating with existing quality systems.

Documentation & Auditing:

• Maintain comprehensive documentation related to sterilization processes, controlled environment areas, and final product release procedures.
• Monitor system performance via monthly reports, audits, and batch record reviews to identify opportunities for process improvement.

Risk Management & Investigations:

• Perform risk assessments, conduct non-conformance investigations, and lead CAPA projects as required.
• Participate in product quality trend analysis and guidance of corrective actions.

Process Development:

• Define, document, and implement procedures for sterility assurance, environmental controlled areas, and product disposition.
• Assist Quality team leadership in the development and maintenance of policies and practices governing behavior, control, and access within Controlled Environment Areas.

Authority & Decision-Making:

• Exercise the authority to recommend and initiate preventive and corrective actions related to product non-conformance and other quality system activities.

Requirements

• Minimum of 5 years of experience in cleaning and sterilization within the medical manufacturing or pharmaceutical industry.
• Extensive understanding of microbiological and sterilization testing, including hands-on experience with sterilization cycle validations and environmental monitoring.
• Proven ability to execute sterility tests and manage sterilization controls effectively.
• Must be well-versed in the following sterilization modalities: ethylene oxide, gamma, and steam.
• Familiarity with FDA regulations, USP, ISO standards, and quality management systems (e.g., ISO 13485).

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.