Senior Quality Engineer

Job Summary

The Senior Quality Engineer will work within the Quality Operations team, under minimal supervision, and is responsible for ensuring the highest standards of product and process quality. This role partners closely with Operations, Engineering, Customer Service, and Sales to drive continuous improvement, support product development, and maintain compliance with regulatory and company requirements. Key responsibilities include, but are not limited to:     

Essential Job Functions

Quality Systems & Compliance

• Implement, maintain, and improve the company’s quality systems.
• Develop and document quality procedures, SOPs, and inspection methods.
• Conduct internal audits and supplier audits; participate in external audits and provide effective representation of quality processes.
• Oversee corrective and preventive actions (CAPA) and nonconformance (NC) activities, ensuring timely investigation, resolution, and communication of results.
• Manage quality-related events including product holds, concessions, and change control.
• Ensure compliance with company policies, procedures, and applicable regulations.

Product Development & Customer Support

• Support product design and development activities, ensuring compliance with design control requirements.
• Develop and oversee comprehensive risk management plans for products.
• Identify and document quality control requirements, ensuring appropriate inspection procedures are followed during production.
• Validate and maintain test methods, inspection criteria, and performance procedures.
• Investigate and resolve customer complaints, returns, and quality-related issues, working closely with Customer Service and Sales.
• Provide quality input for concession requests and change management activities.
• Support First Article Inspections and ensure effective feedback to stakeholders.

Manufacturing & Process Quality

• Partner with Operations and Engineering to ensure process and product quality performance.
• Develop and implement quality strategies for process development, verification, and validation.
• Lead development of risk management plans for processes and equipment.
• Review IQ/OQ/PQ protocols for new and existing processes and equipment.
• Develops and analyzes statistical data to monitor product quality and reliability, establishing KPIs to drive continuous improvement.
• Continuously improve inspection and sampling methods; apply advanced statistical and quality engineering tools.

Continuous Improvement & Leadership

• Lead root cause investigations and drive problem-solving initiatives across functions.
• Mentor and train teams in quality concepts, statistical methods, and risk management practices.
• Provide technical expertise in areas such as test method development, statistical process control, and quality planning.

Promote a culture of quality through proactive engagement, coaching, and leadership in improvement activities.

 General

• Conduct training sessions and provide guidance on quality practices as needed.
• Support cross-functional projects and initiatives to strengthen overall quality performance.
• Support internal processes, including Managing for Daily Improvement (MDI), Integrated Business Planning (IBP), Good Manufacturing Principles (GMP), and Good Documentation Practices (GDP). 
• Support On-Time-Delivery (OTD) and Quality metric targets; seek opportunities to increase productivity and eliminate waste.
• Execute departmental work plans in conformance with company policies, procedures, regulations, best practices, management objectives, priorities, and financial impact on the business.
• Liaise with customers, suppliers, and third parties as necessary, including monitoring work progress.
• Read, interpret, and adhere to applicable drawings, manufacturing specifications, work instructions, regulations, manuals, and quality procedures.
• Attend and participate in applicable meetings and reports on key metrics.
• Maintain company records per applicable regulations and properly execute various forms, reports, and disclosures, as appropriate.
• Exemplify good work practices, behaviors, and leadership traits; operate with integrity; treat others respectfully; demonstrate integrity, reliability, teamwork, initiative, creativity, problem-solving, and decision-making. Supports interdepartmental cooperation.
• Demonstrate clear and effective communication, both verbal and written. Prepares, maintains, and submits accurate paperwork as required, including job reports, timekeeping records, etc.
• Adhere to all applicable environmental, safety, health, and operations procedures and directives. This includes properly using personal protective equipment following manufacturer specifications, Safety Data Sheets (SDS), and company guidelines. 
• Ensure job site safety, promote safe work practices and rectifiy job hazards, including clean work areas.
• Read, understand, and interpret the lockout/tag-out indicators in the work area. 
• Know, understand, and adhere to Company organizational policies and procedures; align with and represent the Company's mission, vision, core values, and cultural tenants.
• Perform other related tasks as assigned, some of which may become essential to the position.

Skills and Abilities

Required Skills and Abilities

• Business acumen capabilities of leading teams, influencing people, using processes to get work done, managing projects to achieve goals, understanding products and markets, utilizing financial data and financial analysis, formulating goals and strategies, analyzing data, solving problems, making decisions, and assessing performance. 
• Business acumen mindset of thinking strategically, building internal and external relationships, outcome-driven, taking action, assuming responsibility, and earning credibility.
• Problem-solving, critical thinking, and mathematics.
• Organizational skills and a high level of attention to detail.
• Excellent communication skills, both verbal and written.
• Interpersonal skills that foster collaboration and positive relationships with stakeholders.
• Demonstrated ability to motivate, lead, and manage by example, fostering a culture of positivity, performance, and engagement.
• Business systems including Microsoft Office programs (i.e., Outlook, Word, Excel), ERP, and MRP. 
• Must be able to wear safety equipment, as required.
• Must be able to understand, read, write, and speak English.

Preferred Skills and Abilities

• Business understanding of external factors, including market segments, customers, competitors, sectors/industries, business model, value proposition/positioning, distribution channels, global/market extension. 
• Experience working in manufacturing with trade terminology and nomenclature.
• Track record in process improvement and lean manufacturing.
• Medical device manufacturing experience.
• A thorough understanding and a working knowledge of all job phases.

Knowledge and Experience

Required Knowledge and Experience

• 5+ years of experience in a related job role.
• Bachelor's degree in a related field with knowledge of technical subject matter
• Or any equivalent combination of education, training, and experience that demonstrates the ability to perform the duties and responsibilities as described, including an internship in a relevant trade. 

Preferred Knowledge and Experience:

• Experience working in manufacturing with trade terminology and nomenclature.
• A thorough understanding and a working knowledge of all job phases.

Physical/Mental Involvement & Environmental Factors

Physical Requirements: While performing this job's duties, employees are regularly required to sit, walk, stand, bend, crouch, crawl, and twist. Reach, push, and pull with hands and arms.  Lift to 50 pounds.  Talk and hear, both in person and by telephone.

Mental Requirements: Employees are regularly required to use written and oral communication skills; read and interpret data, information, and documents; analyze and solve non-routine and complex problems; use math and mathematical reasoning; observe and interpret situations; learn and apply new information or skills; perform highly detailed work on multiple, concurrent tasks; work under intensive deadlines with frequent interruptions, and interact with staff, the public.

Working Conditions: 100% of work takes place inside an industrial office/warehouse environment.  Employees work in proximity to moving machinery, mechanical parts, and vehicles and may have exposure to prolonged loud noise, including sirens, horns, and tooling.  Employees may handle hazardous material or have exposure to toxic or caustic chemicals, biological hazards, and airborne fumes. The noise level is usually mild to moderate 75% of the time.

Disclaimer

Job descriptions are not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee.  Other duties, responsibilities, and activities may be assigned or changed at any time with or without notice.  Job descriptions are developed through observation of work, information from the marketplace, and interviews with workers and supervisors currently performing the job.