This new position is a part of the quality team that supports our Sales and Service Unit of our organization. The position is responsible for the management and administration of the US SSU Quality System. This position will establish and maintain Quality Management systems which meet all regulatory requirements, corporate policies, internal policies and needs of the business.
- Official designee for all Quality responsibilities in the QA Director's absence. Acts as the alternate Management Representative for Quality in the QA Director's Absence.
- Manage all Quality Engineering functions, including but not limited to:
- Manage and/ or participate in continuous improvement projects.
- Drive continuous improvements for the Sales and Service Unit (SSU).
- Work with service and supply chain to evaluate and implement cost reduction objectives.
- Responsible for providing accurate, timely, quality metrics as required by Corporate QA management and the US SSU.
- Executes quality strategies and systems to comply with Quality System Regulations (QSR), Corporate Quality Management System, and all other applicable quality system requirements.
- Responsible for facilitating Management Reviews and escalating content as appropriate to business and/or corporate management.
- Manages and maintains effectiveness of the Quality Management System and manages the resolution of all quality concerns and related issues as required.
- Reviews and approves applicable policies, procedures, and work instructions.
- Carries out product field action and stop shipments when quality concerns arise.
- Maintains current knowledge base of all regulatory and quality assurance related changes within the industry.
- Provides coordination and/or oversight for the following Quality Services and activities: Quality Systems, Complaint management, adverse event reporting and Service quality
- This is not an inclusive list of job responsibilities.
Required Skills and Abilities:
- Must have demonstrated presentation, facilitation skills and the ability to interact and communicate with senior management and Sales/Service/Field staff at all levels.
- Must be able to lead others in the use of critical thinking, problem solving and analysis.
- Must have effective leadership, problem-solving, decision making, influencing and negotiation skills as well as the ability to assess the impact of quality management strategies on business performance.
- Must have in-depth knowledge of all applicable Quality and Regulatory standards (i.e. US FDA Quality System Requirements (QSR), Quality Systems-Medical Devices ISO 13485, European Council Directive concerning Medical Devices (MDD), Canadian Medical Device Regulations SOR/98-282 (CMDCAS), et al.).
Experience and Education Requirements:
- A Bachelor's degree in Engineering, or related science field, or Associate's Degree with equivalent combination of education and experience
- ASQ CMQ/OE (Certified Manager of Quality / Operational Excellence), CQA (Certified Quality Auditor), CQE (Certified Quality Engineer) or Certified by AAMI in Quality System Regulations is highly desirable.
- A minimum of seven or more years of experience in quality assurance, quality control or related functions in a FDA regulated industry or ISO certified organization is required. Seven to ten years of related experience managing and implementing Quality Management systems in the medical device or pharmaceutical or related industry is preferred.
- Experience supporting Sales & Service preferred.
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