Quality Assistant - Blizzard

Job Summary

Reporting to the QA Manager, the QA Assistant is responsible for ensuring that the organisation conforms to quality standards and regulatory requirements. The post holder will be responsible for assisting with the execution of the Quality team duties. They will be responsible for examining products and materials for defects or deviations from specifications of the Quality Management System (QMS). This is a highly visible position that will require attention to detail and the ability to communicate effectively with all levels of team members across the Company.

Oversees and monitors the inspection and testing of materials, parts, and products to ensure adherence to established quality standards. Recommends changes in specifications of materials, parts, and products based on inspection results. May formulate and revise quality control policies and procedures. Working team member that may validate or coordinate the work of others on a support team. Suggests improvements to process, is a knowledge resource for other team members. 

Job holder to promote and adhere to the company values of quality and compliance with current legislation.

 Essential Job Functions

The job holder will undertake some or all of the following responsibilities:

• Perform line inspection prior to production runs; review/approve line clearance documentation
• Perform inspection and release of product labelling prior to production, perform label reconciliation and final record review at completion of production runs.
• Perform in-process inspection of product during production runs; final inspection of product at completion of production runs.
• Supporting the design and maintenance of the Quality System.
• Participate in Internal and External quality audits as directed by the QA Manager
•  Assist in the development of procedures for the test and inspection of articles
• Perform incoming inspection and release of medical devices, device materials, components and subassemblies
• Contributing to the provision of education and training on relevant compliance activities particularly relating to QMS requirements for all SMT employees
• Maintaining distributor records
• Providing Sales Team support for Tenders, new Distributor accounts and product documentation request
• Drafting and contributing to the creation of production process work instructions and assembly records
• Assisting with assembled product release
• Preparation, attendance and contribution to monthly quality management meetings
• Complying with all safety policies, practices and procedures
• Supporting the monitoring and measuring activities, including NCRs, CAPAs 
• Key participant within the QA/RA team in the execution of their duties
• Keeping up to date with current medical device guidelines, legislation and publications, assessing the impact of changes to the organisation
• Risk management Team Member
• Assist with the review of documentation 
• Conducting Internal Audits
• Other duties as assigned

Skills and Qualifications

• Minimum of 2 years previous experience of working in a quality assurance role.
• Experience of working in manufacturing in a medical device or regulated industry
• Training of EN ISO 14971
• ISO 13485 training
• Internal Auditor training
• Internal auditor:
• Personal behaviour (ethical, open minded, diplomatic, observant, perceptive, versatile, open to improvement, collaborative)
• 3x internal audits supervised by a Lead Auditor.

Competencies

Demonstrates (1) ownership and accountability; (2) Demonstrates the ability to: plan, execute, control and deliver; (3) communicate effectively both written and verbal; (4) Microsoft Office experience; (5) Strong attention to detail

Physical Requirements

Performing the duties of this job regularly involves: (1) sitting, (4) hearing/listening (5) repetitive hand movement (15) vision requirements - close vision, adjust focus, colour code

Mental Requirements

This position requires the ability to: (1) maintain an appropriate work pace; (2) comprehend and follow instructions; (3) exercise logic and reasoning; (4) organize and prioritize; (5) read; (6) compose written communication; (7) communicate verbally; (8) problem solve (9) make decisions; (10) count and compute (11) analyse and interpret data; (12) multi-task/re-direct; (13) experience numerous interruptions, (14) This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations

Other Requirements

(1) Business travel required up to 15% of the time; (2) Must fit within company culture

Work Environment

The noise level in the work environment is usually; (1) quiet to moderate

This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned, and activities may change at any time with or without notice.