PURPOSE AND SCOPE:

Provides process guidance and supports the management and control of established Corporate Change Control processes. Responsible for the development, implementation, improvement, and continuous reinforcement of Corporate Change Control processes utilized across all FMCRTG manufacturing sites.  For assigned location(s), acts as the representative for all change control activities conducted in accordance with established QMS policies and procedures.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

A seasoned, experienced professional with a full understanding of quality systems change management, resolves a wide range of issues in creative ways.Applies a structured methodology to assist with change management activities.Identifies and manages anticipated resistance.Supports and engages senior leaders and coaches managers and supervisors with the adoption of new change.Defines and measures success metrics and monitors change progress periodically.As subject matter expert supports change control management at the site level.Responsible for the development, implementation, periodic review, and communication of Change Control process metrics for local FMCRTG manufacturing site(s). Provides support as a Change Control Process Training SME to conduct hands-on training, as required.Facilitates internal training on quality assurance requirements, processes, and proceduresReviews and audits all change control notices to assure compliance to processes.Interfaces with Change Control Administrators to provide guidance on related change issues.Monitors and prioritizes business need in order to complete and close all activities in a timely manner.Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.   May perform audits.Conduct quality assessment reviews for different roles supporting Training deployment.Assess compliance and quality trends, as well as analytical data that drives process improvements and decision making.Create and publish meaningful data across the enterprise. For example, view compliance and quality trends and drill down into specific user groups and training types to determine the root cause of 'overdue' training completions.Drill down to specific 'custom fields' or user attributes to further examine the number of assignments due which could potentially prevent an audit risk.Based on statistical review, conclude major areas of improvement, based on compliance risks followed by efficiency and alignment in the order.Responsible for tracking department metrics and identifying trends.Proactively identifies issues and opportunities to enhance data management and reporting through detailed and high level problem solving to ensure consistent entry and creation of LMS information and delivery world-class services to business partners/stakeholders.Support external agency inspections (i.e. FDA, TuV) utilizing FMCRTG, LLC Front Room / Back Room Inspection process. Normally receives little instruction on day-to-day work, general instructions on new assignments.Mentors other staff as applicable.May provide assistance to lower-level staff with more complex tasks that require a higher level of understanding of functions.Assists with various projects as assigned by a direct supervisor. May lead and oversee the work of others.Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Some travel may be required

SUPERVISION:

None

EDUCATION:

·Bachelor’s Degree required in a technical or related scientific field. ·CQE, CQA, CQM, or Six Sigma certification preferred.

EXPERIENCE AND REQUIRED SKILLS:         

Minimum 8 - 12 years of experience working in a medical device or similar highly regulated industry, within the areas of Quality Engineering, Regulatory Affairs, Quality Assurance Management, Change Control, or Configuration Control. With an Advanced Degree 3 to 6 years of experience may be acceptable. Experience in Learning and Development or Training environment required.·Strong knowledge or aptitude to understand Medical Device QMS requirements, and regulatory requirements including but not limited to FDA CFR 21 820, CFR 210/211, ICH Guidance, ISO 14971 and ISO 13485. ·Demonstrated understanding of product development lifecycles, design change, and document change control. Experience supporting FDA inspections or ISO audits preferred.Experience participating in cross-functional teams.Adept in use of computer software MS Word, Excel, PowerPoint, statistical packages, web-based documentation systems.Ability to organize/balance priorities in a dynamic, fast-paced environment. Works independently with minimal supervision.·Experience with process verification and validation methodologies, manufacturing/production process control methodologies, and risk management and regulatory requirements related to the assessment of product and process changes.·Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, and in-depth understanding of FMCRTG site level products & related processes.·Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, process controls, and document change controls.·Excellent oral communication, report, business correspondence, and procedure-writing skills. ·Exceptional analytical, problem solving, and root-cause analysis skills. ·Ability to handle tasks with competing priorities effectively. ·Demonstrated critical thinking skills with regards to simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, communicating priorities clearly and concisely.

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.
 
Rate: $XX - $XX
 

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity 

 Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws. 

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

 

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.