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Responsibilities:

• Ensure QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, and ISO).
• Drive development and/or modification of Stryker's QMS.
• Assess and quantify requirements for QMS requirements to optimize structure.
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
• Develop and deliver training for QMS areas of expertise.
• Contribute to the development, maintenance, and improvements of policies and procedures.
• Responsible for initiating, reviewing, documenting, and approving Engineering Change Orders (ECO's).
• Represent expertise during internal and external quality system audits.
• Own Corrective Action/Preventative Action (CAPA) for field-based non-conformance.
• Communicate in an effective and timely manner with department leaders regarding effective implementation of corrections/corrective actions.
• Assure proper investigation for Root Cause Analysis using effective Root Cause Analysis tools.
• Set-up and calibration and metrology procedures related to installation and service.
• Coordinate calibration activities for field-based technicians.
• Assure all test equipment is up-to-date on calibration cycle through Calibration Lab and meets calibration requirements.
• Keep field-based technicians notified of calibration status of all instruments in the program.
• Track and maintain up to date the calibration status and records of all instruments, equipment, and tools.
• Identify and initiate procurement of all tools, equipment, and calibration standards to be used for installation and servicing of medical devices.
• Will identify, communicate and cooperate/guide internal and third-party calibration services providers and provide support during process maintenance and services to the instruments, equipment, and tools.
• Review all calibration certificates from third party services to ensure compliance with our procedures.
• Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
• Working knowledge of data collection, data analysis, evaluation, and scientific method.
• Commitment to excellence and high standards
• Excellent organizational, problem-solving, and analytical skills to lead to sound, timely decisions
• Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
• Ability to interface with both technical and non-technical personnel at all organizational levels.
• Proficient with Microsoft Office and ability to learn corporate systems.
• Ability to analyze and adjust to constantly changing quality and regulatory standards
• Ability to analyze and resolve non-routine quality or regulatory issues using independent judgment.
• Must be able to observe and correct minute inconsistencies (e.g. in the written word, form usage, etc.).

Requirements:

• Bachelor's Degree
• 2+ years' experience in quality and/or engineering within a highly regulated environment
• Interaction with regulatory agencies
• Thorough knowledge and understanding of US and International Medical Device Regulations.
• Experience updating and writing procedures (engineering process changes) preferred
• Strong knowledge of Quality Systems (CAPA, audits, metrology, etc.)
• Strong communication, project management and influencing skills.
• Ability to plan, organize, and implement multiple concurrent tasks.
• Strong interpersonal skills, written, oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
• Demonstrated ability to work in cross-functional team environments.
• Experience in compliance risk situations.
• Computer literacy.
• Some travel may be required.