QMS Engineer

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment. SUMMARY 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. This position will serve as the primary contact for site departments, business units, and corporate functions and will work closely with all departments to provide guidance and development opportunities. Be the Champion and subject matter expert for the Quality Systems and Compliance programs. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Ensure the site’s quality system development, effective maintenance and continued compliance with business unit requirements, medical device regulations and standards (i.e., ISO9001) · 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) · Lead the follow-up, negotiation and resolution of issues regarding current and future submissions with appropriate regulatory agencies and ISO registrars. · Responsible for proposing and execution of Quality System improvement opportunities, and developing and maintaining Business Continuity Planning programs. · 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. · 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 Extensive 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 · Develop and maintain QA plans and timeliness of global new product introductions utilizing Advanced Product Quality Planning and Process Optimization specific to the customer. · Support all global training programs specific to their customer by development and implementation of specialized training sessions for all applicable functions. · Review all supplies, internal, and customer discrepancies, coordinate and track the effectiveness of corrective/proactive action efforts. · Conduct periodic review and maintenance of all documentation files; develop appropriate systems for document storage and access. · Interface with all departments as applied to the Policies and Procedures. Knowledge of the U.S. and international quality system regulations, standards and best practices (ISO9001) · Extensive 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 · Support all global training programs specific to their customer by development and implementation of specialized training sessions for all applicable functions. · Conduct periodic review and maintenance of all documentation files; develop appropriate systems for document storage and access. · Interface with all departments as applied to the Policies and Procedures. · Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor. · Comply and follow all procedures within the company security policy. JOB QUALIFICATIONS KNOWLEDGE REQUIREMENTS 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. BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in. Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law. Accessibility Accommodation If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address.