Supervisor, Global Process Alignment

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. Arthrex is actively searching for a Supervisor, Global Process Alignment to manage and lead our initiatives on compliance and continuous improvement of Quality and Regulatory processes.  The successful candidate will build relationships with internal departments to help drive our strategies and continued market growth. Excellent interpersonal, relationship building skills along with three years or more of experience working in Regulated Industry and a Bachelor’s degree are essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

The Supervisor, Global Process Alignment will advance Arthrex’s Mission and Quality Policy by leading initiatives focused on compliance and continuous improvement of Quality and Regulatory processes. This role will drive change to the procedural structure anchored in the evolving Corporate QMS, supplemented with industry best practices towards the developing regulatory landscape, and applied regionally for organizational alignment and functional excellence. The Supervisor, Global Process Alignment will partner with Subject Matter Experts to collaboratively achieve the following objectives for Quality Assurance and Regulatory Affairs:

• Development, compliance, and consistency of GxP processes
• Implementation of evolving procedural documentation structure
• Human impact of processes, including usability considerations and connection to competency assessment employee qualification and proficiency function
• Compatibility of established process with computerized system structures
• Continuous Improvement

Essential Duties and Responsibilities:

1. Collaborate with Quality Systems, Regulatory Affairs, and Business Leads to identify functional areas of increased procedural priority through compliance and/or business risk.
2. Lead SME teams through the process of mapping document structures and individual processes, lending efficiency and clarification expertise as applicable.
3. Develop GxP-compliant procedures that utilize the appropriate language and construct to define terms and processes and establish ownership of foundational elements.
4. Spread functional knowledge of GxP-compliant procedure creation to SMEs.
5. Integrate procedural development, including responsibility mapping, with QMS Technical Training and Competency Training Department to ensure effective deployment and retention of procedures.
6. Apply computerized system and data structuring analysis principles to developing processes.
7. Review and approve GxP procedures and periodic reviews within electronic document management system to ensure technical compliance and connectivity to overall mission.
8. Lead and develop a team of technical writers.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

• Bachelors degree required
• 3 years experience in Regulated Industry Required
• 3 years of progressively responsible experience managing complex projects and personnel required

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Leadership and participation on cross-functional, matrixed teams, resulting in strong collaborative relationships. 
• Fluency in Global markets and business cultures.
• Ability to learn and implement Arthrex organizational structure into responsibility mapping requirements.
• Working knowledge of Project Management Software.
• Lean Six Sigma knowledge preferred.
• Ability to navigate internally and externally across levels. 
• Strong integrity and commitment. 
• Consideration of the relative risks and benefits of potential actions to make decisions. 
• Ability to assess, plan, schedule and manage complex projects in a dynamic environment. 
• Flexibility in changing priorities and evolving regulations and standards. 
• Preference to work in a fast-paced environment.

Reasoning Ability:

Ability to identify and define problems, collect data, analyze established facts, draw valid conclusions, and effectively communicate the information both verbally and in writing to a variety of audiences.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to both appropriately format and develop a clear logic trail to establish conclusions based on an understanding of factual evidence. Ability to critically think; using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Ability to actively learn; understanding the implications of new information for both current and future problem-solving and decision-making.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.