Descripción del Trabajo
This position has the responsibility and authority to lead assigned Quality System processes. In addition, this role will be a primary host for internal audits, customer audits, ISO Registration audits, FDA Inspections and when required lead or support preparing submissions and responses to FDA and ISO Registrars. This position functions as a subject-matter resource for Quality Systems and a primary contact for site departments, business units, and corporate functions.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Be the subject matter expert for the Quality Systems policies, procedures, and applications.
- Strong working knowledge and application of appropriate global medical device regulations, requirements and standards including FDA’s 21 CFR 820, ISO 13485, ISO 9001, ISO 14971
- Support day-to-day quality system activities within the Quality Systems function (i.e., Document and Data Control, Retain and Records Retention, Training Effectiveness, Non-Conformance and Corrective and Preventive Action Programs, Change Control, Supplier Audits, Supplier Corrective Action Requests, Electronic System Development/Validation, Quality Data Review and Management Review, Risk Management, Internal/External/Customer Audits, Agency Inspections and Quality Improvement Initiatives)
- Developing strategies and hands-on-execution of continuous improvements and programs that align with customer needs and all applicable Medical Device Regulations
- Lead the support of currently marketed products including review of engineering changes, labeling, promotional material, product changes and documentation of changes requiring government approval.
- Evolve existing processes/systems to ensure timely escalation identification of product quality and compliance issues.
- Responsible for collecting data, performing statistical analysis to investigate trends, provide interpretations/solutions, and draw conclusions
- Support the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes
- Develop and implement Quality programs, including tracking, analyzing, reporting, and problem solving to overcome program challenges / delays
- 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
- Expert knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21 CFR 820, ISO 13485)
- Experience with compliance assessments, gap assessments and risk management assessments.
- Experience with organizational change management practices, Lean / Six Sigma methodologies (Six Sigma Black Belt preferred), program and system integration efforts
- An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
- Strong interpersonal skills and communication skills:
- Passionate about our mission to constantly make our products and processes better
- Able to assist in finding creative solutions around constraints
- Strong leadership, collaboration and relationship building skills. Must be able to work in a team environment and influence change without alienating others.
- Must have a high tolerance for ambiguity and adaptive to a dynamic and fast-paced environment
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 in a management or supervisory position
- Or a combination of education, experience and/or training
- American Society of Quality (ASQ), Certified Quality Auditor (CQA) or Regulatory Affairs Professional Society (RAPS) Certification is a plus.
The anticipated pay range for this role is $81,517 - $118,014 - $154,621. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity.
As part of the total rewards package, this position is eligible for a short-term incentive based on performance. In addition, Jabil offers benefits to enhance your health, wealth and resilient self. These include medical, dental, and vision insurance plans; 401(k) retirement plan and employee stock purpose plan; and paid time off.