Job Description

Description

Join Safeguard Medical – Where Purpose Meets Innovation

At Safeguard Medical, we’re not just shaping the future of emergency medicine—we’re saving lives. We combine deep expertise with world-class equipment to empower first responders to act confidently and effectively when every second counts.

Our mission is clear:
To equip and enable responders at every skill level to preserve life in any environment.

Our vision is bold:
To simplify emergency medicine so that all responders have the confidence and tools to intervene when it matters most.

Our purpose is powerful:
To bring together life-saving products and the knowledge of emergency medical skills that preserve life.

From category-leading medical devices to hyper-realistic SIMBODIES simulations, and a presence in key markets around the world, we’re building a global movement—one that gives first responders the tools they need to make a difference in the toughest conditions. If you’re driven by impact, inspired by innovation, and ready to grow in a company that’s changing lives—this is your moment.

About the Role

We’re on the lookout for a passionate Quality Engineer II to join our team onsite full time in Huntersville, NC. This isn’t just a job—it’s a chance to be part of something bigger. At Safeguard Medical, every role plays a part in our mission to preserve life and deliver excellence across the globe.

What You’ll Be Doing in This Role

As a Quality Engineer II, you’ll be right at the heart of our mission to preserve life.  The Quality Engineer, as part of a cross-functional team, with primary responsibility for quality management related to Operational support, ensures that applicable elements of the Quality System and external standards are being followed. As the voice of Quality, the Quality Engineer applies quality best-practices including team-based and statistical tools and techniques, strong root cause analysis skills, and promotes the value and use of such tools throughout the organization.  This role will lead and execute projects of varying complexity and must be able to connect well with all levels of the organization from operators and inspectors to management.  The role should require minimal oversight from management and possess strong root cause analysis skills. 

Your key objectives:

· Executing Quality Engineering activities in relation to Operational support, including support of risk management creation, classification of quality characteristics, technical drawings and specifications, design verification and validation, and process validation activities.

· Performing root cause analysis of identified issues and identifies appropriate corrective and preventive action. Supports NC and Complaints/CAPA/SCAR systems within QE Team.

· Using 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.

· Supporting activities related to clean room monitoring and environmental controls.

· Working closely with Quality Control team to ensure adequate resources to support manufacturing

· Ensuring compliance with all practices in accordance with the Quality Management System. 

· Providing technical support for process improvements, supplier changes or design changes including but not limited to creation or updates to risk management documentation, ensuring comprehensive documentation is available, adequate records are produced, and change management is implemented for such changes.

· Working with quality control, manufacturing, and warehouse personnel to implement processes and process improvements including related documentation

· Executing control measures and drives resolution when supplier quality issues are identified.

· Supporting supplier management principles such as supplier selection, qualification, certification, and performance improvement. 

· Applying the concepts of producer and consumer risk and related terms, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc. Interprets and selects variable, attribute, and zero-defect sampling plans. Supports incoming inspection processes.

· Developing and validates test methods with oversight as needed. Identifies and applies metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conducts measurement system error studies such as Gage R&R.

· Understanding the implementation of appropriate internal, national, and international requirements and standards. Performs internal and external audits as necessary (virtual and in-person) including supplier audits 

· Defining, identifying, and applying product and process control methods such as developing control plans, identifying critical control points, and developing and validating work instructions.

· Contributing to corporate technical programs (e.g., system improvement, remediation, harmonization) in areas such as those identified in this position description 

Requirements

You won’t just be filling a role—you’ll be making a difference. Every decision, every action, every idea you bring to the table helps responders around the world save lives when it matters most.

Is This You?

We’re looking for someone who’s ready to jump in and make a difference. Could that be you?

• You thrive in a team and bring a positive, can-do attitude to everything you do
• You’re passionate about helping others and want to be part of something that truly matters in emergency medicine
•  Detail-driven and reliable under pressure. 
• Self-directed, demonstrating ownership and accountability with an aptitude and willingness to learn.
• Team-oriented personality 
• Demonstrates the ability to plan, execute, control, and deliver on project tasks and overall goals.
• Strong written and verbal communication skills.
• Excellent problem-solving skills 
• Strong organizational skills 
• Collaborative personality with the ability to lead and influence others effectively without authority while creating and maintaining a positive environment.
• Ability to develop and maintain relationships with medical professionals, sales force, and cross functional team members.
• Understanding of change management, conflict resolution and team dynamics.
• Excellent critical thinking skills, including experience implementing the DMAIC thought process and structured root cause analysis, while employing a risk-based thought process.
• Ability to identify project and design risks and create mitigation strategies.
• Ability to independently make sound decisions with available information, through a risk-based approach.
• Ability to analyze data using statistical methods.

You possess the following:

· Bachelor’s degree in a STEM discipline or equivalent experience required.

· 3-6 years’ experience in the medical device or pharmaceutical field preferred.

· Technical knowledge and understanding of the medical device industry.

· Must have experience in risk identification, mitigation, and risk management

· Experience with manufacturing processes and related documentation preferred

· Experience with sterilization and packaging validation activities preferred.

· Minitab experience preferred.

· Experience in 3D modeling and drafting preferred.

· Proven track record of executing multiple projects / initiatives simultaneously, exhibiting appropriate prioritization of tasks and completing them with a sense of urgency

If you’re nodding along, we’d love to hear from you.

Why Safeguard Medical?

This is more than a career move—it’s a chance to join a fast-paced, purpose-led company where your work truly matters. You’ll be surrounded by passionate people, cutting-edge products, and endless opportunities to grow.

• Be part of a mission-driven organization with global impact
• Work with life-saving technologies  and innovative solutions
• Join a collaborative, supportive, and inclusive team
• Build your career in a company that invests in people and progress

  Our Culture: Powered by Our DNA

At Safeguard Medical, our culture is built on values that drive us every day:

• Ownership – We take charge, own our impact, and push for success.
• Initiative – We act boldly and do what’s right, fast.
• Curiosity – We ask “why?”, explore better ways, and embrace diverse views.
• Candor – We speak openly and respectfully to align and move forward.
• Humility – We lead selflessly, knowing success is shared.

We believe in learning from each other, valuing every voice, and creating a space where everyone belongs—regardless of background, identity, or ability.

What You’ll Get in Return

We believe great people deserve great rewards. Here’s what we offer to support your wellbeing, growth, and success (benefits may vary by country):

• Comprehensive insurance packages – peace of mind for you and your loved ones with medical, dental, vision and life insurance
• Competitive pay & performance bonus – because your impact deserves recognition
• Retirement support – employer contribution to help secure your future
• Generous time off allowance – time to recharge and enjoy life outside of work
• Employee Assistance Program (EAP) – confidential support when you need it most
• Tuition reimbursement &referral programs – invest in your growth and help us grow too

Ready to Make a Difference?

Ready to join our team? We’d love to hear from you. Click here Safeguard Medical - Job Opportunities to learn about future opportunities.

Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. 

Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. 

The above statements are not an exhaustive list of all required responsibilities, duties and skills for this job classification.