Quality Engineer III

Provides technical leadership and strategic direction for quality engineering initiatives that ensure product product enhancements processes suppliers and quality systems meet company customer and regulatory requirements

Quality Systems Leadership

Serves as a subject matter expert in quality systems supplier quality auditing regulatory compliance continuous improvement and new product development

Lead development implementation maintenance and continuous improvement of Quality Management System Regulations (QMSR) processes in accordance with FDA Quality Management System Regulations ISO 13485

Serve as a subject matter expert for quality system processes including CAPA nonconformance containment complaint handling auditing document control and risk management

Lead complex investigations involving recurring systemic high-risk or customer-impacting quality issues

Review and approve CAPA investigations root cause analyses corrective actions and effectiveness verification activities

Evaluate quality system performance metrics and recommend strategic improvements.

Support organizational audit readiness and regulatory compliance initiatives

Assist management in developing departmental quality objectives and performance metrics

Product and Process Quality

Lead resolution of complex product process and supplier quality issues utilizing advanced problem-solving methodologies

Analyze quality trends manufacturing metrics field performance data warranty information and customer feedback to identify systemic improvement opportunities

Drive corrective and preventive actions that improve product quality process capability and customer satisfaction

Establish quality metrics and monitoring systems that support business objectives

Participate in cross functional collaboration with Research and Development (R&D) to ensure regulatory compliance and specification development is executed

Provide technical leadership in statistical analysis process capability studies and quality improvement initiatives

Review and approve quality-related investigations and recommendations

Develop and present high-level reports regarding problematic quality issues to outline mitigation activities

Supplier Quality Leadership

Lead supplier quality management activities for critical suppliers and strategic supplier development initiatives

Conduct supplier audits and assessments to evaluate supplier compliance capability and performance

Lead supplier corrective action activities and verify implementation and effectiveness of corrective actions

Partner with Purchasing Engineering and Operations to improve supplier performance and mitigate supply chain risks

Support supplier qualification and approval activities for new suppliers and new product introductions

Work with management to develop supplier quality performance metrics and improvement plans

Continuous Improvement Leadership

Lead cross-functional continuous improvement initiatives utilizing Lean Six Sigma DMAIC and other quality methodologies

Facilitate teams focused on reducing defects improving efficiency lowering costs improving customer satisfaction and enhancing quality performance

Identify and prioritize opportunities for quality operational and business process improvements

Track and communicate project performance measurable business impact cost savings and quality improvements

Promote a culture of continuous improvement throughout the organization

New Product Development and Validation

Serve as a senior quality representative on new product development and product launch teams

Lead quality planning activities for new product introductions including risk management First Article Inspection Review (FAIR) Board validation and design transfer activities

Review and approve Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs)

Provide quality oversight for process validation activities including DQ/IQ/OQ/PQ protocols and reports

Ensure quality and regulatory requirements are effectively incorporated into product development activities

Support design verification validation and risk management activities

Auditing and Regulatory Compliance

Lead internal quality system audits supplier audits process audits and finished device/ component audits

Serve as a primary quality personnel during customer audits third-party audits and regulatory inspections

Identify compliance risks and lead corrective actions to closure

Interpret regulatory and quality standard requirements and provide guidance to management and cross-functional teams

Support maintenance of ISO 13485 certification and compliance with FDA Quality Management System Regulations (QMSR) and other applicable standards

Leadership and Mentorship

Provide technical leadership and mentorship to all Quality personnel

Review investigations audit findings CAPAs and improvement initiatives completed by quality staff

Lead cross-functional teams focused on resolving quality issues and implementing sustainable improvements

Present quality metrics regulatory updates audit results supplier performance data and improvement initiatives to management

Assist management in establishing quality objectives priorities and strategic initiatives

Promote a culture of quality compliance accountability and continuous improvement

General Responsibilities

Ensure all safety and security rules are strictly observed and any accidents incidents or injuries are promptly reported to management

Travel domestically and internationally as required to support supplier audits business initiatives regulatory activities and quality projects

Complete the annual CTPAT Security Training

Develop goals and objectives and measure outcomes to ensure goals are met

Focus on continuous improvement and consistently demonstrate good business judgment

Work effectively with all Pride departments to exceed internal and external expectations

Pride retains the discretion to modify duties and/or assign other duties as necessary

Must be a team player friendly professional detail-oriented and honest

Must have the ability to:

Multi-task problem-solve and prioritize in a fast-paced working environment

Manage multiple complex projects simultaneously

Plan develop and execute tactical and strategic quality initiatives

Organize work manage multiple priorities and meet deadlines

Influence decision-making across all level of the organization

Foster cross-functional relationships that promote cooperation and consensus decision making

Apply quality tools methodologies and regulatory requirements

Interpret technical drawings specification procedures and regulatory requirements

Apply understanding of Geometric Dimensioning and Tolerancing (GD&T)

Apply understanding of Institute of Printed Circuits (IPC) standards

Apply working knowledge of Six Sigma concepts

Design and implement inspection and/or Rework Fixtures

Influence positive change through collaboration and data-driven decision making

Travel up to 30% of the time internationally and domestically as business needs dictate

Lift/push/pull 40lbs

Must have:

Basic Computer Aided Drafting (CAD) drafting/modeling

Basic understanding of electrical engineering concepts

Commitment to continuous learning and professional development

Advanced understanding of quality engineering principles and quality management systems

Expertise in root cause analysis and structured problem-solving methodologies

Intermediate working knowledge of Microsoft Office Word and Excel

Excellent presentation verbal and written communication skills

Demonstrated initiative and accountability

Strong leadership development and coaching skills

Strong organizational skills to schedule tasks and develop realistic action plans while being sensitive to time constraints and resource availability

Advanced statistical process skills root cause and failure analysis skills

At least 5 years of experience in Quality Engineering Manufacturing Engineering Quality Assurance or a related engineering discipline

At least 5 years of experience working within a regulated manufacturing environment

At least 5 years of experience performing internal supplier process or quality system audits

At least 5 of experience participating in or leading Continuous Improvement (CI) teams and quality improvement initiatives

At least 5 years of Quality Assurance experience implementing and maintaining quality improvement plans in a manufacturing environment preferred

At least 3 years of experience in quality management systems including ISO 13485 or equivalent preferred

At least 3 years of experience supporting or leading quality investigations CAPAs nonconformance management or process improvement activities preferred

At least 2 years of experience supporting Quality Management Systems such as ISO 13485 ISO 9001 FDA Quality System Regulations or equivalent standards preferred

Current or previous successful employment experience with Pride Mobility Products Corporation preferred

Bachelors Degree in Engineering or a related field

Masters Degree in Engineering preferred

American Society for Quality (ASQ) Certified Quality Engineer (CQE) preferred.

American Society for Quality (ASQ) Certified Quality Auditor (CQA) preferred.

Lean Six Sigma Green or Black Belt preferred

Must be legally authorized to work in the United States without sponsorship now or in the future

This job description is not intended to be all-inclusive

This is a safety sensitive position

In exceptional circumstances some of the physical requirements of this position may be modified or eliminated as a reasonable accommodation for a person with a disability as defined by the Americans with Disabilities Act

Pride Mobility Products/Quantum Rehab is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex gender identity sexual orientation race color religion national origin physical or mental disability protected Veteran status age or any other characteristic protected by federal state or local law. Pride Mobility Products/Quantum Rehab is an Affirmative Action Employer with obligations under VEVRAA and Section 503 of the Rehabilitation Act of 1973 for protected veterans and individuals with disabilities.

If you are a person with a disability a disabled veteran or require a reasonable accommodation or assistance in completing an application for employment please contact our human resources department at 1- x1250.

Required Experience:

IC