Quality Engineer

• Participate in global Quality Engineering activities in software product development, manufacturing, and support including engineering design review, verification/ validation activities.
• Able to define design document requirements for process and test method validation within Design Control and Software Development Life Cycle {SDLC). Reviews and approves software lifecycle deliverables.
• Directly influences project direction and scope, guides product development teams through design validation and regulatory compliance and assures robust product vs. customer requirements.
• Applies established quality and engineering methods to the investigation and solution of software quality problems. Supports CAPA {Corrective Action Preventive Action) and FCA (Field Corrective Action) activities as required.
• Participates, through the creation and review of improvements of software development, software processes, and documentation processes.
• Supports supplier qualification and maintenance activities. Performs SCAR {Supplier Corrective Action), and process deviation activities.
• Participate in internal and external (i.e., FDA, Registrar, Notified Bodies) audits.
• Understands and assesses the impact of a change on the safety and efficacy of a software product, device, process performance, and internal/external customer expectations worldwide.
• Participates in Risk Management activities. Assesses internal and external risks associated with specific actions, quantifies risks, seeks input from others, and identifies actions to limit the exposure of the division.
• Supports and provides oversight to non-product software lifecycle activities including review and assessment of software activities {suppler evaluations, validation, lifecycle deliverable documents) to ensure compliance with applicable procedures, standards, and regulatory requirements.
• Participates in multi-site and business wide software lifecycle activities to accomplish quality system objectives.
• Investigates and analyses impact of failure within and across product lines. Uses technical, compliance, product, and process knowledge to assist in identifying preventative actions. Able to assure effectiveness of actions are taken to prevent reoccurrence.

Requirements:

• 4-year degree (Bachelor's Degree) in a scientific or technical discipline preferred or 10+ years of experience in a related field.
• 1-3 years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes.
• Excellent communication skills, problem solving capability and attention to detail is critical.
• Knowledge of regulations and standards affecting software development and overall design control for medical devices.
• Experience in applying quality regulations and standards {e.g., 21CFR 820, ISO 13485, ISO 14971, IEC62304, Cybersecurity- ISO 27001), and working knowledge of current and applicable GMP regulations is required.
• Use of analytical skills and ability to organize work in a logical and thorough manner.
• Capable of analysing data to support the development of strategies to effectively manage, enhance, mitigate, and/or resolve potential issues.
• Challenges data adequacy based on experimental design concepts. Recognizes when issues may have an impact on areas outside of their immediate area of responsibility.
• Highlights issues in a timely manner and presents possible resolutions. Seeks additional information when problem is beyond area of personal expertise.
• Experience in reviewing, and executing validation and change control documents, authoring SOPs, Protocols {IQ, OQ, PQ) of Process Control Systems
• Demonstrates project management skills.
• Possesses interpersonal skills to negotiate and reconcile differences.
• Flexibility to adapt to changing assignments and ability to effectively prioritize.