This position has the responsibility and authority to lead assigned Quality System processes. In addition this role will lead internal audits, customer audits, ISO Registration audits, FDA Inspections and when required prepare submissions and responses to FDA and ISO Registrars. This position will serve as the primary contact for site departments, business units, and corporate functions and will work closely with direct reports to provide guidance and development opportunities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Be the Champion and subject matter expert for the Quality Systems and Compliance programs.
· Ensure the site’s quality system development, effective maintenance and continued compliance with business unit requirements, medical device regulations and standards (i.e., U.S. – FDA, ISO 13485, ISO 9001)
· Lead department activities within the Quality Systems function (i.e., Document and Data Control, Retain and Records Retention, Training, Corrective and Preventive Action, Change Control, Deviation, Supplier Audits, Supplier Corrective Action Requests, Electronic System Development/Validation, Management Review, Risk Management, Auditing, Agency Inspections and Quality Improvement Initiatives)
· Ensure the accuracy of the regulatory contact and submission log is maintained; provide regulatory guidance to various internal project teams as necessary.
· Lead the follow-up, negotiation and resolution of issues regarding current and future submissions with appropriate regulatory agencies and ISO registrars.
· Continue to develop and enhance current regulatory knowledge at both the local and national levels to support surveillance activities.
· Lead the support of currently marketed products including review of engineering changes, labeling, promotional material, product chances and documentation of changes requiring government approval.
· Responsible for proposing and execution of Quality System improvement opportunities, and developing and maintaining Business Continuity Planning programs.
· Responsible for writing, reviewing and approving validations in accordance with customer and regulatory requirements.
· Establish, maintain and report Quality System metrics to local level teams, management and global business units.
· Ensure timely and comprehensive closure of systems, including adherence to all in-process milestones. Facilitate prioritization and resource discussions with Change/Improve and other stakeholders.
· Support the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes.
· Manage expenses; provide support to budget planning, scheduling, and site wide process improvement opportunities.
· Perform all duties in alignment with the Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements
· Other duties as assigned
· Knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21 CFR 820, ISO 13485)
· Some experience with compliance assessments, gap assessments and risk management assessments.
· Experience with program change management practices, lean or six sigma, program and system integration efforts
· Strong computer skills; Word, Excel, PowerPoint
· Strong interpersonal skills are required. Must be an effective team player intra-departmentally and cross-functionally.
· Strong leadership, collaboration and relationship building skills. Must be able to work in a team environment, influence change without alienating others.
· Must have a high tolerance for ambiguity
EDUCATION & EXPERIENCE REQUIREMENTS
· Bachelor’s degree required (Quality, Regulatory, Engineering, Business or Life Sciences)
· Master’s degree is desired (Quality, Regulatory)
· 6 + years of industry experience within Quality and/or Regulatory, and managing high performing teams.
· American Society of Quality, Certified Quality Auditor (CQA) credentials, is required.
· Regulatory Affairs Professional Society (RAPS) Certification is desired.
· Or a combination of education, experience and/or training.
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