Job descriptionOur client, a world leader in power generation, is looking to bring on a Documentation Control Coordinator (Administrative style role) to join their team for a 12+ month contract. Role will require onsite work (hybrid ok) in Phoenix, AZ.
Overview: The Doc Control Coordinator will manage quality systems, processes, and procedures to assure product safety and quality by driving business alignment to correct industry requirements and business objectives by managing quality system design, controls, and continuous improvement.
The Documentation Control Coordinator will:
Key responsibilities include:
- Establishing, maintaining, and improving the QMS of the brand to meet ISO13485 regulation requirements
- Ensuring follow up and implementation of corrective actions that are raised by deviations, internal audits, or regulatory inspection
- Responsible for managing processes and procedures to assure product quality and safety
- Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs)
- Owning the development and maintenance of policies and procedures for departmental functions
- Planning and conducting internal audits
- Supporting local programs and quality issue resolution
- Influencing business compliance to Quality policy, Quality Management System procedures
- Influencing participation in compliance to internal and external regulations
- Influencing quality system metrics such as Corrective and Preventive Action, training metrics, completion, and complaint resolution metrics
- Review/Aware of and comply with the brand Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
- Complete all planned Quality & Compliance training within the defined deadlines Identify and report any quality or compliance concerns and take immediate corrective action as required Zero repeat findings from previous internal and external audits
- Assure site and business is properly prepared for external and internal compliance inspections by the results of the inspections finding no systemic or warning letter findings.
- 100% implementation of all quality system procedures, work instructions and requirements Assure specific site goals are established and met for compliance, training, CAPA, and production process controls.
- Bachelor’s degree plus 3 years’ experience working in a regulated medical device environment, quality control/assurance or regulatory assurance or manufacturing.
- Ability to effectively communicate.
- Demonstrated experience in the medical device industry and knowledge of quality system, regulations and policies
- Demonstrated ability to develop & lead process implementation & improvement in a team environment
- Experience with some or all of the following:
- Design controls, design verification and validation activities
- Production and process controls
- CAPA, complaints and risk management
- Understanding of product quality improvement using tools
- Experience performing internal audits
- Demonstrated effective interpersonal and networking skills
- Prior experience using word processing, spreadsheet, and presentation software
- Demonstrated ability to successfully comprehend & carry out/execute actions
- Effective oral and written communication skills Analytical & problem-solving skills/root-cause analysis
- Exceptional conflict-resolution skills
- Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner
- Ability to prioritize and drive multiple programs Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
- Accepting constructive criticism and dealing calmly and effectively with high-stress situations.
- This includes continuing to persevere and remaining calm in challenging or frustrating circumstances
- External Focus: Understanding customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function and considering the external impact of business activities and decisions on the external environment Inclusiveness:
- Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others
- Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely