Location: Indianapolis,IN, USA
Kimball Electronics is committed to working with and providing access and reasonable accommodation to applicants with mental and/or physical disabilities. If you think you may require accommodations for any part of the recruitment process, please send a request to ...@kimballelectronics.com . All requests for accommodations are treated discreetly and confidentially, as practical and permitted by law. No Visa sponsorship is available for this position. Kimball Medical Solutions provides 3 weeks of PTO starting your 1st year in addition to 10 paid holidays. Potential monthly incentive bonus based on company performance. Major health, dental, vision, and complementary insurances starting day 1. We offer a 50% match on your first 6% of 401k contribution with opportunity for an employer contribution annually.Position OverviewThe mission of the Production Specialist is to provide the operations department with essential support to train, direct and oversee the work of production associates for Medical Device manufacturing processes. The production specialist is meticulous, possesses a greater level of knowledge, skills, abilities and continuously strives to improve. This position reports to a Production Supervisor within the Operations department of a growing Medical Device contract manufacturer focused on capital equipment, drug delivery devices and disposables.Quick SummaryThe Production Specialist is responsible for assisting their supervisor in the oversight of work area staff, to ensure that quality products are manufactured efficiently and effectively in compliance with released documentation and company policy. This includes the verification of proper batch record documentation according to Product Related Procedures, Quality System Procedures, and Good Documentation Practices. In addition, the Production Specialist will be accountable for a team of associates and their results.Basic Background RequirementsThis position will require:Medical manufacturing experience is preferredAbility to work on pharmaceutical products with the end patient in mindAbility to Communicate effectively (verbal, written, documentation)Experience with MS Office and comfortable working with different computer programsMust be self-motivated, organized, exhibit willingness to change under pressure.Must be able to identify continuous improvement opportunities, present root cause analysis (including data to support your analysis), and a plan to implement.Able to work independently and as a member of a teamThe ability to work with all levels of the organizationReact to change productively and handle other tasks that may be assigned.Ability to review and understand procedures and interpret assembly drawings effectively.Ability to work on your feet at the actual location of production.Ability to reach, bend and lift as required by production requirements.Ability to understand business, legal and regulatory requirementsWorks overtime as required to provide excellent customer satisfactionOperate equipment, fixtures and test stations per procedures and training as needed.Maintain clean and safe working environment in accordance with company policies.Maintain regular attendance according to the company's attendance guidelines.Maintain general knowledge of the certification and regulatory requirements contained in ISO-13485, and FDA CFR/GMP Medical Device RegulationKey Performance Objectives Short Term: (0 to 3 months) Learn and adopt Kimball Electronics philosophies and cultureLearn KEIND Quality system requirementsLearn Good Documentation PracticesComplete inventory forms as requiredBuild relationships with Operations, Quality and Material Handling team membersMaintain clean and safe working environment in accordance with company policies.Maintain regular attendance according to the company's attendance guidelines.Contribute to 6S & Continuous Improvement (CI) for your areaMidterm: (3 to 6 month)Ability to review procedures for accuracy.Provide improvement ideas for review & drive implementationReport production in the ERP system and on Work Order documentationLead and be accountable for team and their resultsLong term: (6 to 12 months) Improve procedures and Processes for production efficiency.Provide training for other production specialistsInitiate and complete Engineer Change OrdersComplete Yellow Belt Training (Green Belt Preferred)As a global company, we value a culture of curiosity, diversity of thought, and innovation from our employees, customers, and partners. Kimball Electronics is committed to a diverse and inclusive work environment where all employees' differences are celebrated and supported, and everyone feels safe to bring their authentic selves to work. Kimball Electronics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, ancestry, religion, sex, national orientation, sexual orientation, age, marital status, disability, gender identity, gender expression, Veteran status, or any other classification protected by federal, state, or local law. We strive to create a workplace where every voice is heard, and every idea is respected.