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Manager Quality Engineering and Quality Control

Company: CyberCoders
Location: Austin
Posted on: July 14, 2019

Job Description:

Manager Quality Engineering and Quality Control
Based in Austin, TX we are one of the world's contemporary medical device companies that provides preserved human cardiac and vascular tissues, surgical adhesives and sealants, cardiac lasers and implantable end-stage renal disease access grafts for the repair of complex cardiac and vascular reconstruction surgeries. We have been in business since 1984, our products and tissues have been implanted in about 900,000 patients worldwide.Due to continued company growth we are looking for a candidate who has 5+ years managing a Quality Engineering and Quality Control team in the medical device industry with a history of successful participation in Product Development teams and effective project management.If you are a Manager Quality Engineering and Quality Control with experience, please read on!


What You Will Be Doing
Provide leadership, direction, management, and development of Quality Engineering and Quality Control strategies and objectives for the Design, Sustaining Engineering, Manufacturing, and Inspection processes. Establishes objectives and creates and implements action plans.Manage, coach, and develop a high performing Quality Engineering and Quality Control team that meets objectives and delivers results, guides the organization for strategic and tactical issues, and implements continuous improvements.Develop, manage, and deliver training programs for Quality Engineering and Quality Control processes for new and existing employees and on-going site compliance.Manage supplier qualifications and perform detailed audits to ensure global supplier compliance and capabilities, including reconciliation of inspection methods and evaluation of proposed supplier changes for product development and sustaining activities.Develop strategies for timely submission and approval of verification and validation plans and protocols associated with product/process according to US and International standards and regulations e.g. QSR, ISO, MDD and site procedures.Manage sterilization processes environmental monitoring, sterilizers, and sterilization.Implement all Quality Control inspection processes in process, final, and product release for all our products.Review and approve Change Control submissions to ensure efficiency and compliance to Quality System for US and International requirements for Product Development and Sustaining activities for all On-X products.Must be a hands-on leader and practical thinker, able to identify and come up with solutions and roll-up sleeves to get things done.Serve as lead project manager for Quality Engineering and Quality Control process improvements and integrations.Lead Quality investigation of non-conformances, corrective/preventive actions, and complaints for all On-X products, processes, and systems.Incorporate US and International regulations and standards through the product life cycle, designing and developing required inspection and process control methodologies.Manage Quality oversight of hazard and risk analyses for new products and sustaining products, including DFMEA and PFMEA.Provide authoritative guidance about Six Sigma principles i.e. Sampling, Acceptance Criteria, DOE, Statistical Process Control, Root Cause Analysis, FMEA, control charts, capability analysis as well as guidance on Design Control elements to Product Development team members and Manufacturing Staff.
What You Need for this Position
Bachelor's degree in Engineering field required.5+ years experience in medical device industry 5+ years managing a Quality Engineering and Quality Control team in the medical device industry with a history of successful participation in Product Development teams and effective project management.5+ years experience leading and implementing complex processes/systems, site expansions, and remediating/integrating processes at global site level.Proven ability to develop high performing individuals and drive team member engagement. Ability to collaborate with and support team members, coordinate interdepartmental activities and resolve individual conflicts and issues.Ability to develop comprehensive project plans to lead multiple projects simultaneously without supervision. This includes creating detailed and accurate project tasks and schedules, interfacing with project team members and other support personnel and solving project-related conflicts and issues.Ability to lead risk management, DFMEA, and PFMEA sessions is requiredExperience managing sterilization programs environmental monitoring, sterilizers equipment, sterilization, validation, and testing/sterilization suppliers, inspections, and product release. Strong working knowledge of Design Controls, Validation, Software, Manufacturing process controls, Complaints, Non Conformances, and CAPA processes.Experience with ISO 14971, Usability Engineering, ISO13485, MDD, and 21CFR Part 820. Understanding of other US and International regulations and standards related to medical devices is required.Proven ability to maintain key quality metrics/indicators to track compliance performance and analyze data to implement improvements and streamline processes and procedures.Demonstrated successful application of analytical quality tools including Six Sigma, Lean, SPC, and statistical methods to diagnose and correct improper quality control practices, with experience in CMM Programming, Gage R&R and Inspection Plan development required. DFSS training preferred.
What's In It for You
- Vacation/PTO- Medical- Dental- Vision- Relocation- Bonus- 401k

So, if you are a Manager Quality Engineering and Quality Control with 5+ years of professional experience, please apply today!
- Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Keywords: CyberCoders, Austin , Manager Quality Engineering and Quality Control, Engineering , Austin, Texas

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