Quality Assurance Manager
11911 North Creek Parkway South Bothell, Washington 98011 | Direct Hire
Position Title: Quality Assurance Manager
Position Description: Our Eastside client is looking to bring on a Quality Assurance Manager to join their team. This position will be responsible for managing and executing a subset of quality assurance policies, programs and initiatives.
Specific functional responsibilities include management and supervision of Quality Engineers (manufacturing support, product verification, and process validation) and Document Control personnel. Duties include management of CAPA system, product non-conformances, and internal auditing.
- Contribute to the development of systems and quality standards for medical devices to ensure compliance with current regulatory requirements.
- Assist in Validation and Verification activities pertaining to design and sustaining Engineering projects;
- Support process validation (IQ-OQ-PQ) projects for new products and product iterations
- Support/manage continuing cleanroom validations
- Responsible for the failure investigation and corrective and preventative actions of manufacturing issues; which includes assigning responsibilities, tracking, reporting status, and review of requests and actions plans for appropriateness and compliance to requirements.
- Write and coordinate efforts for the development and implementation of new and updated Quality System procedures.
- Supporting Production personnel by resolving process and material related quality problems in support of the various manufacturing organizations.
- Provide data collection, review, and analysis of processes supporting production quality; Serve as quality representative for Material Review Board (MRB) activities.
- Assure tool qualification, product/process performance qualification, and sustaining engineering design changes are performed in compliance with Quality Management System.
- Responsible product risk management for new and existing products.
- Carry out and manage other activities as assigned in support of overall quality system.
- Plan and manage departmental activities in accordance with agreed budgets and timescales.
- Suggest, plan and support implementation of quality system tools and improvements.
- Present progress updates, plans, and proposed budgets to Senior Management. Establish standard QA metrics, as appropriate.
- Liaise with customers and suppliers as necessary (where impacted/affected by quality issues).
- Monitor, apply and implement changes and additions to regulatory and requirements and standards within affected areas of responsibility.
- Provides expertise, leadership and support in Quality management for resolution of Quality issues within manufacturing organization, engineering and material management
- Support validation projects; review and approve protocol; manage deviation if it occurs
- BS in related scientific or technical discipline preferred
- Successful experience in the medical device industry, of which, 5 years should be in quality assurance or a regulatory environment.
- 3+ years of experience in managing technical personnel
- Strong working knowledge of ISO 13485, QSR, & MDD regulatory standards
- Cleanroom and sterilization experience is required,
- Embedded systems, and software development experience is preferred.
- ASQ and auditor certification and experience are preferred.
- Excellent communication skills with the ability to interact with all levels in the organization.
- Knowledge of document control systems; including records management, change order process, and document distribution and retrieval.
- Successful experience working in team environment.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.