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Jabil Inc Quality Systems Manager - J2244304 in Monument, Colorado

At Jabil,we empower the brands who empower the world its our reason forbeing and the guiding force thats driving us to become themost technologicallyadvanced manufacturing solutions provider on the planet.Whether were servingone of the worlds biggest and best known brands or the coolest techstartups, our resolve never wavers. We share common desires with thesebrands: to make the world a better, safer and cleaner place.JOB SUMMARYThis position has the responsibility and authority to lead assigned QualitySystem processes. In addition this role will lead internal audits, customeraudits, ISO Registration audits, FDA Inspections and when required preparesubmissions and responses to FDA and ISO Registrars. This position will serveas the primary contact for site departments, business units, and corporatefunctions and will work closely with direct reports to provide guidance anddevelopment opportunities.ESSENTIAL DUTIES AND RESPONSIBILITIESBe the Champion and subject matter expert for the Quality Systems andCompliance programs.Ensure the sites quality system development, effective maintenance andcontinued compliance with business unit requirements, medical deviceregulations 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, SupplierAudits, Supplier Corrective Action Requests, Electronic SystemDevelopment/Validation, Management Review, Risk Management,Auditing, Agency Inspections and Quality Improvement Initiatives)Ensure the accuracy of the regulatory contact and submission log ismaintained; provide regulatory guidance to various internal project teams asnecessary.Lead the follow-up, negotiation and resolution of issues regarding currentand future submissions with appropriate regulatory agencies and ISOregistrars.Continue to develop and enhance current regulatory knowledge at both the localand national levels to support surveillance activities.Lead the support of currently marketed products including review ofengineering changes, labeling, promotional material, product chances anddocumentation of changes requiring government approval.Responsible for proposing and execution of Quality System improvementopportunities, and developing and maintaining Business Continuity Planningprograms.Responsible for writing, reviewing and approving validations in accordancewith customer and regulatory requirements.Establish, maintain and report Quality System metrics to local levelteams, management and global business units.Ensure timely and comprehensive closure of systems, including adherence toall in-process milestones. Facilitate prioritization and resource discussionswith Change/Improve and other stakeholders.Support the effectiveness of the Quality Systems and Compliance programs byworking collaboratively with other stakeholders to ensure effective andcompliant processes.Manage expenses; provide support to budget planning, scheduling, andsite wide process improvement opportunities.Perform all duties in alignment with the Jabil Corporate Code of Ethics,Corporate and Global policies, Employment Labor Laws, Health RegulatoryAgency Regulations, and Safety RequirementsOther duties as assignedJOB QUALIFICATIONSKNOWLEDGE REQUIREMENTSKnowledge of the U.S. and international medical device quality systemregulations, standards and best practices (21 CFR 820, ISO 13485)Some experience with compliance assessments, gap assessments and riskmanagement assessments.Experience with program change management practices, lean or six sigma,program and system integration effortsStrong computer skills; Word, Excel, PowerPointStrong interpersonal skills are required. Must be an effective team playerintra-departmentally and cross-functionally.Strong leadership, collaboration and relationship building skills. Must beable to work in a team environment, influence change without alie

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