In partnership with the site Quality Manager, you will carry out the Quality Inspection function for the site during the Night Shift (final hours/schedule to be agreed with the successful Candidate) .
You will be accountable and responsible for ensuring best practices pertaining to the use of quality tools are developed and deployed at the site.
Direct, coordinate, and review all activities of the quality assurance inspectors & processes in manufacturing and in other applicable areas as required. Establish product and process quality requirements. Serve as a liaison between the Quality function, other site functional groups, and the customer in ensuring quality requirements are met and documented. Supports the execution of major quality initiatives / projects at the direction of the site Quality Manager. Investigates problems and recommends corrective actions for recurring and non-recurring discrepancies. Creates motivating environment and empowers others. Assists in building cohesive teams, bringing out the best from team members while fostering teamwork and collaboration.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Identifies and manages performance through daily, weekly, monthly metrics, with clear stakeholder communication and issues elevation.
- Applies systematic technical problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Identifies, plans, and executes quality requirements resulting from internal and external changes.
- Uses the Quality Management System (QMS) in developing and executing the appropriate processes for consistent, technical, risk-based decision making.
- Responsible for inspecting components and products to ensure internal and customer specifications are met.
- Manpower deployment in support of production schedule commitments.
- Drive quality awareness in all direct personnel including the production supervisors and support functions.
- Communicates clearly and effectively to the Quality Manager and the Quality Engineering team on all issues that require additional support, escalation and/or resources to effectively resolve discrepancies.
- Support and educate manufacturing personnel in the interpretation of specifications and procedures governing the manufacturing area.
- Promote a “Quality First” culture to the employee base.
- Servant leader to direct reports to include establishing individual goals & objectives, provide regular performance feedback, and support employee development & training.
- Assists in the hiring and training of departmental staff and activities to ensure high performance, accountability, interdependence, and collaboration.
- Minimizes customer complaints due to product quality through effective corrective and preventive actions.
- Ensure compliance of project activities to appropriate standards and regulations (FDA, ISO, etc.).
- Compile, document and interpret data required to monitor and analyze process related performance.
- Support the development and/or implementation of site, customer, lean, or global quality initiatives with the use of project management methods and tools.
- Adheres to all safety rules.
- Perform other duties and responsibilities as assigned.
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
- Typically reports to Management. Direct supervisor job title(s) typically include: Site Quality Manager or Sr. QA Manager
- Job is directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management). Job title example(s) of employees directly supervised:Quality Lead Inspectors, Quality Inspectors, Quality Technicians
- Strong proficiency in carrying out inspection requirements to enable company’s business goals and objectives with ability to devise and implement strategy to achieve targets.
- Proven track record of successful change management accomplishments, implementing and management continuous productivity and cost reduction programs.
- Strong and convincing communication skills.
- Experience in internal, supplier, third-party & FDA quality audits / inspections.
- Able to assess and recommend improvements to manufacturing environment.
- Strong knowledge of Quality Management System, 21 CFR Part 820/210/211 & ISO 13485.
- Ability to learn plastic injection molding and final device assembly SOPs.
- Excellent problem-solving abilities.
- Strong analytic skills and multitasking abilities as well as identifying and resolving issues with limited supervision.
- Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
- BA/BS preferred.
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