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An experienced Senior Quality Engineer with people management or supervisory experience looking for the next step in their career will also be considered!
Manages the identification, implementation, and support of quality assurance activities to support the business quality system. Provides technical and administrative guidance to Quality Assurance, Manufacturing, and suppliers of raw materials or finished medical devices. Required to communicate in an effective manner with internal employees, regulators, and suppliers/consultants and contractors. Must be committed to corporate goals of customer satisfaction and continuous improvement. Direct reports include senior engineers, engineers, and technicians.
Principal Duties and Responsibilities
- Determine and define quality assurance requirements from review of engineering drawings and/or specifications, industry standards, government specifications or other applicable source documents.
- Manage quality control activities related to production including incoming inspections, audits, process validations.
- Ensures compliance of quality systems to the QSR, other applicable regulations/standards, and internal procedures, including but not limited to validation.
- Ensures suppliers, contractors and consultants performing systems work related to quality systems comply with regulations, standards, and internal procedures
- Develop and administer effective data collection and reporting system to meet regulatory requirements and management information needs.
- Actively monitors data sources and collects data where necessary to identify process requirements and significant process improvement opportunities.
- Leads implementation of quality improvement projects.
- Manage quality control investigation activities related to customer complaints.
- Monitor, report out on and drive improvement in corporate Quality metrics
- Responsible for device history record review and product release.
- Provides resources, including the assignment of trained personnel for performance of work and assessment activities to meet requirements.
- Develop direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting performance reviews.
- Translate department goals into individual objectives for direct reports.
- Support internal audit program for the business.
- Responsible for site metrology program
- Leading cross-functional teams in product and process development
- Serves as coach and mentor for new engineers
Expected Areas of Competence
- Lead and motivate team members through feedback and stretch assignments. Establishes and maintains high levels of credibility. Collaborates effectively across the organization, leverages resources from other parts of the organization to build commitment and achieve results.
- Demonstrate ability in selecting, interviewing, training, coaching, motivate, discipline, and direct people.
- Extensive knowledge of the Quality System Regulation and Associated regulations and standards.
- Requires hands on system and process validation experience
Education/ Experience Requirements
- Degree in Manufacturing or Quality Engineering discipline, or
Bachelor’s degree in another field plus a minimum of 5 or more years’ experience in a quality engineering or regulatory compliance role.
- Suitable people management experience