The role will be responsible for ensuring the company's products meet the highest quality standards and comply with all relevant regulations and industry standards. The Quality Engineering Manager plays a critical role in ensuring the safety, efficacy, and reliability of the company's products while developing the Quality Engineering team members and fostering a culture of compliance within Safeguard Medical. This position is on-site in our Harrisburg and/or Huntersville facility.

Essential Job Functions

• Manage and lead a team of quality engineers and technicians, providing guidance, training, and support to ensure their professional development and performance
• Ensure quality assurance activities are carried out effectively
• Oversee testing and validation processes, as necessary, including protocol and report development, to ensure compliance with quality standards
• Monitor and analyze quality metrics and performance indicators to identify trends, areas for improvement, and opportunities for process optimization
• Conduct or participate in risk management activities and implementing risk management strategies to identify and mitigate potential quality issues for new and existing products and processes
• Oversee the management of customer complaints ensuring that they are investigated, analyzed, and resolved in a timely manner, as well as CAPAs to address root cause and prevent recurrence of quality issues
• Review Change Orders and assess quality impact of product and process changes
• Promotes a culture of continuous improvement within the department and the broader company
• Proactively drive activities to meet and/or exceed company objectives
• Establish and maintain quality control procedures, including inspection/control plans, testing protocols, and documentation requirements
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality considerations are integrated into new product development, and manufacturing processes
• Lead or participate in internal and external audits to assess compliance with quality standards and regulatory requirements.
• Uses appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying Statistical Process Controls (SPC), identifying relationships between variables, and statistical decision making
• Support activities related to clean room monitoring and environmental controls
• Collaborate with suppliers, contract manufacturers, and the internal supply chain team to ensure adherence to quality standards and specifications, while applying supplier management principles such as supplier selection, qualification, certification, and performance improvement, traveling to such partners when necessary
• Develop and validate test methods while applying metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices, conduct measurement system error studies such as Gage R&R
• Apply the concepts of producer and consumer risk, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc., interpret and select variable, attribute, and zero-defect sampling plans
• Keep up-to-date with industry trends, regulatory changes, and best practices in quality engineering for medical devices, and implementing necessary updates to the quality management system
• May act as project lead for functional and cross-functional projects, including generation of the project definition, plan, and requirements
• Perform other related duties and responsibilities as assigned

Qualifications:

• Bachelor's degree in a scientific or related field
• Minimum of 5 years of experience in quality engineering for medical devices
• Strong understanding of quality management systems, regulatory requirements, and industry standards specific to medical devices, including a working knowledge of 21 CFR 820, EUMDR, ISO 13485:2016, ISO 14971:2019 and IEC 62366-1:2015
• Strong understanding of the product development process
• Extensive experience with root cause analysis and statistical data analysis
• Establishes and fosters an environment of strong collaborative relationships with internal, cross-functional partners, suppliers, and service providers.
• Demonstrated ability to manage and prioritize assigned project tasks to deliver on-time, on-quality, and on-budget
• Oversees or participates in the development and execution of detailed validation test protocols
• Experience with sterilization and packaging validation activities preferred
• Excellent leadership, communication, and problem-solving skills to effectively manage a team and drive continuous improvement in quality processes and outcomes
• Detail-oriented with strong organizational and project management skills
• Strong attention to detail and ability to work in a fast-paced environment
• Demonstrated ability to collaborate effectively with cross-functional team members
• CQE Certification preferred
• Minitab experience preferred.
• Certified ISO 13485 auditor preferred
• Six Sigma/Lean Certification preferred
• Consistently demonstrates and upholds the culture and values of the organization internally and externally. Must fit within the Safeguard Medical culture