Quality Engineer III

Pride Mobility & Quantum Rehab•Duryea, PA

About The Position

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.

Requirements

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 levels of the organization.
Foster cross-functional relationships that promote cooperation and consensus decision making.
Apply quality tools, methodologies, and regulatory requirements.
Interpret technical drawings, specifications, 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 years of experience participating in or leading Continuous Improvement (CI) teams and quality improvement initiatives.
Must be legally authorized to work in the United States without sponsorship now, or in the future.

Nice To Haves

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.
Master’s 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.

Responsibilities

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.
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.
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.
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.
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.
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.
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.
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.