Quality Assurance Manager
- Job Reference: 10196
- Date Posted: 11 September 2017
- Recruiter: Paul Mitchell Associates
- Location: London
- Salary: £30,000 to £35,000
- Sector: Administration & Business Operations
- Job Type: Permanent
- Duration: ASAP
- Work Hours: Full Time
Our client a successful manufacturing organisation is looking to recruit an experienced Quality Assurance Manager who responsible for the strategic oversight of all Quality Assurance Activities and all applicable regulations and standards for which the Company is certified to.
This role is a field based role covering locations in South of England.
Working directly with Quality Assurance associates and leadership to provide guidance and support. Interacting with senior management to advise necessary continuous improvement efforts so that systems and processes are in line with overall company strategy and quality policy. Strategically providing technical input and advise / implement necessary process and documentation changes. Making decisions based on customer, associate and company best interests.
Is responsible for Quality Assurance activities performed on several locations across the UK.
*Oversee and ensure Quality Assurance program, Quality Assurance leadership and associates. Attend to and guide inspections as required.
*Oversee systems that effect quality of product.
*Provide support regarding the revision or implementation of the documentation of these systems, including procedures, work instructions, and forms.
*Understand product workflow; follow product from start to finish, ensuring finished good meets written expectations/specifications. Review design process of finished goods as it relates to customer specifications.
*Direct CAPA program and support Lead Auditor to ensure CAPA and audit programs (internal and external) are sound.
*Lead customer audits, including audit preparation, documentation, follow-up, and closure.
*Conduct audits for Quality Management System.
*Support supplier evaluation program, including supplier audit program. Review program and advise Purchasing where issues exist.
*Oversee the application of business Quality Management Systems.
*Provide technical support regarding the revision or implementation of process documentation, including procedures, work instructions, and forms.
*Support compliance with ISO standards the Company is certified to (incl. standards revisions).
*Evaluate and advise management on current regulations and standards, new regulations and/or standards and proposed changes.
*Maintain the Quality Management System (QMS).
*Support and advise necessary continuous improvement projects as a result of periodic trend reporting; management review; complaint investigation; supplier, customer, and internal audits; and any other relevant quality event.
*Create, implement, and maintain process improvements, key initiatives, projects, and tasks, as assigned.
*Deploy effective root cause analysis.
*Identify training needs and provide training as requested. Prepare, conduct, and advise necessary training on quality assurance concepts and tools.
*Set team goals and develop a strategy the team will use to reach its goals. Delegate tasks and set deadlines. Oversee day-to-day operation and recognize high performance and reward accomplishments.
*Conduct team meetings to update members on best practices and continuing expectations.
*Lead Complaint Investigation efforts.
*Oversee responses to customer questionnaires, quality agreements and specifications.
*Guide Management Review preparation and lead meetings.
*Conduct periodic review of complaint process, audit program, and related quality programs.
*Perform other duties as assigned.
Education/Training, Experience and Certifications:
*Bachelor's degree in Engineering, Life Sciences or related discipline
*5 years applicable experience
*1 years leadership experience
*ASQ CQM - OE, ASQ CQA or equivalent, preferred.
*Strong interpersonal and people management skills.
*Working knowledge of ISO 9001, ISO 13485, cGMP's and regulations applicable to the Business and comparable international regulatory agencies.
*Working knowledge of ISO 14001 would be beneficial
*Working knowledge of Cleanroom operations, certifications and environmental monitoring acc. ISO 14644, understanding of sterilization methods/processes
*Ability interact with all levels of the organization
*Ability to prioritize the department's work and ensure deadlines are met
*Functional knowledge of Microsoft Outlook, Word, and Excel, (or equivalent), highly desired
*Previous exposure and experience with automated inventory control systems strongly recommended.
*Demonstrated knowledge and experience with software systems and integration with the quality system.
*Excellent communication skills - verbal and written
*Significant project management experience.