Job Description:
The Quality Engineering Supervisor provides leadership and technical support to ensure that quality control processes, in-process inspections, and documentation reviews are executed in compliance with applicable standards and regulations. This position is responsible for overseeing a team of quality engineers and supporting their professional development—particularly during onboarding and role transitions. The Supervisor will collaborate closely with the QA Management to ensure the effective allocation of resources, timely resolution of nonconformances, and adherence to company and regulatory requirements. This role serves as the first line of supervision, providing guidance, coaching, and direction to the team to ensure operational excellence and continuous improvement.
Main Responsibilities:
· Coordinate and schedule daily activities of quality engineers to ensure a continuous and compliant manufacturing process.
· Monitor and report quality performance metrics, including in-process controls and manufacturing holds (QTs).
· Participate in Tier II and III forums, ensuring quality actions and commitments are completed on time.
· Support and mentor new engineers during their onboarding period, fostering skill development and technical growth.
· Ensure that all QC department personnel follow approved procedures and Good Documentation Practices (GDP).
· Collaborate with QA Management to maintain adequate staffing levels and optimize workflow efficiency.
· Oversee containment activities to prevent the release of nonconforming products.
· Ensure consistent product flow and timely release of conforming products to customers.
· Maintain compliance with ISO 13485 and 21 CFR Part 820 requirements. · Organize work areas according to Stryker standards, ensuring proper use of tools and equipment.
· Monitor staffing levels versus budget and identify opportunities for process improvement.
· Respond promptly to management requests and inquiries.
· Provide training and coaching to associates on inspection methods, quality procedures, and documentation standards.
· Support internal, external, and regulatory audits.
· Conduct performance management activities including hiring, training, performance reviews, and disciplinary actions as necessary.
· Manage employee schedules, timecards, and overtime in accordance with management directives.
· Conduct internal regulatory compliance audits to verify corrective actions and close nonconformance issues.
· Commit to and actively promote Environmental, Health, and Safety (EHS) policies.
· Perform other duties as assigned by the QA Manager.
Skills:
Education and experience
· Master’s degree in Science, Engineering, or a related discipline.
· 3+ years of professional and/or supervisory experience in a quality or manufacturing environment.
· Demonstrated understanding of inspection methods for electromechanical and mechanical devices.
· Experience in a regulated manufacturing environment (medical devices preferred).
Behaviors /Values
Competencies
· Strong knowledge of ISO 13485, GMP, and quality systems requirements.
· Proficiency in quality engineering tools and methods (e.g., risk-based thinking, statistical sampling, process capability, Gage R&R).
· Lean or Six Sigma certification is a strong advantage.
· Excellent communication, leadership, and mentoring skills.
· High level of proficiency in Microsoft Word, Excel, and PowerPoint.
· Strong analytical and problem-solving abilities, with attention to detail.
· Proven ability to manage multiple tasks in a fast-paced environment.
· Effective interpersonal and collaboration skills; fosters open communication, respect, and trust within the team.
· Acts as a change agent with a continuous improvement mindset.
· Fluent in English (minimum B2 level, both written and spoken).
Values and Behaviors
· Demonstrates integrity, accountability, and a commitment to quality.
· Builds strong cross-functional relationships and supports teamwork across departments and sites.
· Proactively supports the QA Manager and the organization’s strategic goals.
· Encourages a culture of learning and professional development among engineers.
Travel Percentage: 10%