Job Description

Opportunity Description

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.

Job Duties

Quality Systems & Compliance

• Implement, maintain, and continuously improve the company’s quality management systems in compliance with applicable standards and regulations.
• Develop, document, and enforce quality procedures, SOPs, inspection methods, and control plans.
• Conduct and support internal, supplier, and external audits; represent the organization effectively during regulatory and customer audits.
• Manage corrective and preventive actions (CAPA), nonconformances (NC), concessions, product holds, and change control processes to ensure timely resolution and documentation.
• Ensure adherence to company policies, GMP, GDP, and all relevant regulatory requirements.

Product Development & Customer Support

• Partner with cross-functional teams to support product design and development under design control requirements.
• Develop and maintain product risk management and control plans, including test methods and inspection criteria.
• Validate test methods and ensure inspection and performance procedures meet quality and regulatory standards.
• Investigate and resolve customer complaints, returns, and quality-related issues, collaborating closely with Customer Service and Sales.
• Provide quality input for change management, concession requests, and First Article Inspections, ensuring effective feedback and documentation.

Manufacturing & Process Quality

• Collaborate with Operations and Engineering to ensure process and product quality performance meets standards.
• Develop and execute quality strategies for process validation, verification, and continuous improvement.
• Lead the development and review of IQ/OQ/PQ protocols for new and existing processes and equipment.
• Monitor product quality and reliability through statistical analysis, trend monitoring, and key performance indicators (KPIs).
• Continuously improve inspection, sampling, and testing methods using advanced statistical and quality engineering tools.

Continuous Improvement & Leadership

• Lead root cause investigations, corrective actions, and cross-functional problem-solving initiatives.
• Mentor and train staff in quality systems, risk management, and statistical methodologies.
• Provide technical expertise in test method validation, statistical process control, and quality planning.
• Promote a culture of quality, accountability, and continuous improvement through active engagement and leadership.

General & Administrative

• Conduct and support training, internal initiatives, and cross-functional quality improvement projects.
• Support key operational processes including Managing for Daily Improvement (MDI), Integrated Business Planning (IBP), On-Time Delivery (OTD), and productivity initiatives.
• Prepare, maintain, and submit accurate documentation, reports, and records in compliance with company standards.
• Liaise with customers, suppliers, and third parties to ensure alignment on quality expectations and project progress.
• Participate in meetings, track and report on quality metrics, and ensure clear communication across departments.
• Uphold safety, environmental, and operational procedures; ensure personal and team adherence to all EHS policies, PPE requirements, and lockout/tag-out protocols.
• Exemplify company values and professional conduct, demonstrating integrity, teamwork, reliability, initiative, and effective problem-solving.
• Perform other related duties as assigned to support departmental and organizational objectives.

Education

• 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.

Experience & Skills Required

Required:

• Experience: Minimum 5+ years of relevant experience in a manufacturing or related technical role.
• Industry Knowledge: Strong understanding of manufacturing environments , including trade terminology, processes, and standards.
• Business Acumen: Demonstrated ability to lead teams, influence cross-functional groups, manage projects, and achieve business objectives. Skilled in data-driven decision-making, financial analysis, goal formulation, and performance assessment.
• Strategic Mindset: Proven ability to think critically and strategically, build productive internal and external relationships, drive results, and take ownership of outcomes.
• Technical & Analytical Skills: Proficient in problem-solving, critical thinking, and applied mathematics for data analysis and process improvement.
• Communication & Interpersonal Skills: Exceptional verbal and written communication abilities; fosters collaboration and positive relationships with stakeholders at all levels.
• Leadership: Demonstrated success in motivating and managing teams by example, cultivating a culture of engagement, accountability, and continuous improvement.
• Systems & Tools: Proficient in Microsoft Office Suite (Outlook, Word, Excel) and experienced with ERP/MRP systems .
• Other Requirements:
• Ability to read, write, and communicate fluently in English.
• Must be able to wear required personal protective equipment (PPE) and adhere to all safety standards.

Preferred:

• Strong business understanding of external factors such as market segments, customers, competitors, and industry trends , as well as familiarity with business models, value propositions, and distribution channels.
• Proven track record in process improvement, Lean manufacturing , and continuous improvement methodologies .
• Experience in medical device or other regulated manufacturing industries .

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