Job Description Summary

The Quality Assurance Site Leader is responsible for providing manufacturing and engineering process support in accordance with regulation, documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcements of established Quality Assurance fundamental practices that are utilized in the local business. The role involves leading a team in the areas of design, design transfer, manufacturing, distribution and post market activity.

Job Description

Key responsibilities/essential functions include:

·        Assists in ensuring 100% quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility

·        Influences site compliance to Regulation, Standard , Quality policy, Quality Management System procedures.

·        Supports the development, communication and implementation of a strategy to ensure compliance

·        Responsible for the development, implementation and continuous improvement of process effectiveness and efficiency at the site

·        Develop process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to CAPA ,PSR, DMS, Lean Manufacturing, engineering studies, etc.

·        Leads process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Pans (Product or Process specific plans) and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts

·        Supports continuous product and process improvement through analysis for non-conformances, and investigates, develops and implements effective and complaint solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program)

·        Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc.  Supports design mitigation efforts.  Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.

·        Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation

·        Engages cross-functionally to drive Quality Systems Requirements.

·        Provides guidance and facilitates problem resolution, resource utilization, career counseling, coaching and mentoring of team members

·        Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager

·        Identify and report any quality or compliance concerns and support corrective actions

Required Qualifications:

1.      Bachelor’s Degree or higher.

2.      Minimum of 10 years of professional experience, including at least 5 years of quality assurance experience in the medical device industry, minimum of 5 years supervisory/management experience.

 

He:

1.      Understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485

2.      Knowledge of Quality Management System tools, continuous improvement methodologies and in-depth understanding of site level products & related processes

3.      Expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management.

4.      Collaboration, negotiation & conflict resolution skills

5.      Excellent communication skills (written and oral)

6.      Ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance

7.      Understanding product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing/production process control methodologies and servicing in a medical device environment

8.      Experience leading and implementing complex changes

9.      Experience of performing internal audits and participating in external audits

10.   Exceptional analytical, problem solving & root-cause analysis skills

11.   Ability to multi-task & handle tasks with competing priorities effectively

12.   Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrate experience interfacing with regulators

13.   Understanding of applicable quality and regulatory requirements for PDX pharmaceutical equipment and cyclotrons

14.   Ability to communicate effectively with global central teams.

Additional Information

Relocation Assistance Provided: Yes