Position title: Quality Specialist
Reports to: Quality Manager/Designee
Job summary: Maintain resources, capabilities, and systems while ensuring integrity and overall quality of products, materials, and procedures in a cost-effective and value-added manner, directly for the company and our customers
Duties and responsibilities:
- Monitor and maintain strict compliance to safety rules and procedures while on the premises for all internal/external staff
- Responsible to maintain and manage all documentation related to ISO 13485, ISO 9001 and ISO 14001including safety and environment records and documents
- Monitor and maintain adherence to all GMP, Clean room, and ISO procedures for all internal/external staff
- Reinforce a quality culture that includes generation and maintenance of quality processes, systems, and standards
- Ensure execution of all Quality Assurance tasks through the production process in accordance with internal procedures, and customer directed requirements
- Oversee scheduled production, accompanying reporting, and tasks of all related personnel
- Ensure all paperwork and records meet Quality Assurance and customer contracted requirements (Manufacturing Control Sheets), PPAPs and APQP
- Ensure “Lot and Batch” traceability for all customer products
- Training new, temporary, student, and agency staff
- Direction, training, and support to all quality inspectors, packaging and quality associates
- This is a brief summary of the daily duties and responsibilities. Management may alter or assign these or other duties and responsibilities as required
Knowledge, skills, and abilities:
- Computer savvy, knowledge of Excel including Visio and other office programs
- Detail oriented & precise
- Ability to read, write, speak, and clearly understand English
- Maintain a constructive relationship with all production personnel
- Thorough understanding of quality assurance procedures and safety requirements
- Superior analytical, management, communication and interpersonal skills
- Ability to evaluate and document employee performance
- Great sense of initiative, “Hands-On”, and procedure driven
- Adept with metrology standards and techniques
- Attention to detail and ability to evaluate significance of final product quality criteria
- Statistical analysis and implementation of statistical methods for tracking product quality
- Motivated to continue educational comprehension of statistical techniques
Credentials and experience:
- College diploma or equivalent experience
- ISO 13485, 14001 and 9001 Internal auditor certificate
- Preferred ASQ – CQT and/or CQE
- Fluent computer skills
- WHIMIS training
- Knowledge of GMP, Clean room, and ISO procedures
Special requirements:
- Task oriented to customer driven work ethic
- Available to work overtime, holidays, weekends, and the ability to work flexible, and/or rotating shifts
Authority:
- Shut down molding equipment in the event of unstable quality productivity
- Evaluation, disciplinary, and corrective actions regarding all staffing within your control
Job Types: Permanent, Full-time
Salary: $60,000.00-$70,000.00 per year
Benefits:
- Dental care
- Extended health care
- Vision care
Flexible Language Requirement:
Schedule:
Supplemental pay types:
Work Location: In person
