Senior Staff Quality Engineer

Regulatory Jobs; Arlington (TN); On-site; USD 103,000 - 171,000; Full time

Benefits offered by this job

Travel 10%

Job summary

Stryker in Arlington, TN is seeking a Senior Staff Quality Engineer to provide quality leadership across manufacturing operations. You will own investigations, CAPAs, MRB dispositions, and work with cross-functional teams to ensure compliance with FDA, ISO 13485, and GMP.

The role emphasizes data-driven decision making, risk management, and continuous improvement across facilities, with travel as needed. The position requires a strong background in quality engineering, regulatory affairs, and

Qualifications

• Bachelor’s degree in engineering or related technical discipline.
• 7+ years in Quality Engineering, Quality Assurance, or Regulatory Affairs in a regulated industry.
• Strong understanding of ISO 13485, GMP and quality system requirements.
• Expertise in CAPA, Risk Management, RCA, Audits, Validation, and statistics.
• Experience with risk-based methodologies and statistical techniques.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent communication across all organization levels and cross-functional influence.
• Willingness to travel and manage multiple priorities in a fast-paced environment.

Responsibilities

• Lead quality oversight for manufacturing processes and product quality.
• Own investigations, NCs, CAPAs, and root cause analysis.
• Collaborate with Operations, Engineering, and Supply Chain on quality and regulatory alignment.
• Lead internal and supplier audits and support regulatory interactions.
• Manage MRB dispositions, product holds, and risk mitigation activities.
• Provide SME input on risk management, CAPA, change management, validation, and statistics.
• Drive quality-related changes and risk assessments through data-driven decisions.
• Analyze quality metrics and drive continuous improvement.
• Support validation strategies and manufacturing transfers across facilities.
• Coach and mentor quality teams and represent Quality in reviews.

Skills

Quality leadership

CAPA ownership

Risk management

Data-driven decision making

Statistical methods

Lean Six Sigma

Process improvement

Audits

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in engineering or related field

Job description

Work Flexibility: Onsite

Stryker is seeking a Senior Staff Quality Engineer in Arlington, TN to provide quality leadership across manufacturing operations and cross-functional business teams. This role is responsible for driving quality excellence through risk management, CAPA ownership, supplier quality oversight, audit participation, and continuous improvement initiatives. The successful candidate will serve as a quality subject matter expert, ensuring compliance with FDA, ISO 13485, GMP, and Stryker Quality System requirements while influencing business performance through data-driven decision making.

What You Will Do

• Provide quality leadership and oversight for manufacturing processes and product quality.
• Own and drive investigations, nonconformances (NCs), corrective and preventive actions (CAPAs), and root cause analysis activities.
• Partner closely with Operations, Engineering, Supply Chain, and cross-functional business teams to provide quality oversight and direction on product and process performance while ensuring compliance with ISO 13485, GMP, regulatory requirements, and Stryker Quality Systems.
• Lead investigations and resolution of internal and supplier-driven nonconformances (NCs), driving timely containment, root cause analysis, corrective and preventive actions (CAPAs), and effective closure.
• Disposition nonconforming products through Material Review Board (MRB) processes, issue nonconformances as appropriate, and support product holds, potential product escapes, and quality risk mitigation activities.
• Serve as a subject matter expert in risk management, CAPA, change management, concession management, validation, statistical techniques, inspection methods, sampling plans, process capability, and quality system requirements.
• Develop, assess, and approve quality-related changes, concessions, and risk management activities through data-driven decision making and sound quality engineering principles.
• Analyze quality metrics and KPI trends, identify opportunities for improvement, and implement corrective actions that drive operational excellence and continuous improvement.
• Lead and support local and global quality initiatives, utilizing Lean, Six Sigma, Human Error Prevention, and risk-based methodologies to improve product quality and manufacturing performance.
• Optimize inspection methods, statistical sampling approaches, and process controls to ensure product quality, process capability, and compliance with established standards.
• Participate in and lead internal, external, customer, supplier, and regulatory audits, including audit preparation, logistics coordination, response development, and engagement with regulatory agencies.
• Support validation strategies, execution, and approval activities while ensuring compliance with applicable quality and regulatory requirements.
• Lead or support manufacturing transfers, process changes, and product launches across facilities, ensuring quality objectives and regulatory requirements are maintained.
• Manage supplier quality relationships through performance monitoring, quality issue resolution, nonconformance management, corrective actions, and continuous improvement initiatives.
• Coach, mentor, and provide technical leadership to quality professionals and cross-functional teams on quality systems, risk management, CAPA, problem-solving methodologies, and regulatory compliance.
• Represent Quality on local, global, and corporate review boards, providing expert input, technical guidance, and strategic recommendations that support business objectives and product quality.

What you need

• Bachelor’s degree in engineering, Quality, Life Sciences, Regulatory Affairs, or a related technical discipline.
• 7+ years of experience in Quality Engineering, Quality Assurance, or Regulatory Affairs within a regulated industry; medical device experience preferred.
• Strong understanding of medical device manufacturing processes, ISO 13485, GMP, and quality system requirements.
• Demonstrated expertise in quality engineering principles including CAPA, Risk Management, Root Cause Analysis, Audits, Validation, and Statistical Methods.
• Experience with risk-based methodologies and statistical techniques, including Process Risk Assessments, Statistical Sampling Plans, Process Capability Analysis, and Gauge R&R studies.
• Strong analytical, problem-solving, critical thinking, and decision-making skills with exceptional attention to detail.
• Ability to communicate effectively across all levels of the organization and influence cross-functional stakeholders.
• Proven ability to lead quality initiatives, mentor others, and drive compliance with technical, regulatory, and quality requirements.
• Self-starter with the ability to manage multiple priorities in a fast-paced, collaborative manufacturing environment.
• Strong interpersonal, conflict resolution, and relationship-building skills with a customer-focused, stakeholder-oriented approach.

Preferred

• Medical device industry experience supporting manufacturing operations.
• Lean Six Sigma certification or formal training.
• Experience interacting with regulatory authorities such as FDA, TÜV, Notified Bodies, Ministry of Health (MoH), or other regulatory agencies.
• Experience supporting supplier quality, process validation, inspection optimization, and manufacturing transfers.
• Demonstrated success applying continuous improvement methodologies and Human Error Prevention principles within manufacturing environments.
• Experience leading cross-functional quality projects and representing Quality during audits, inspections, and business reviews.
• Willingness to travel as needed and collaborate within a multi-site global organization.
• Developing overlays, develop inspection methods, Gages, GD&T understanding, Print reading.Insert detailed job description here.

United States of America Pay Ranges:

• USN: $102,600 - $171,000 USD Annual

Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.