Production Specialist

Production SpecialistThe 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.The 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.This 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 ObjectivesShort 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)Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Kimball Electronics we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!We're proud to be an equal opportunity employer and consider qualified applicants without regard to race, color, religion, sex, national origin, ancestry, age, genetic information, sexual orientation, gender identity, marital or family status, veteran status, medical condition or disability or any other characteristic protected by applicable federal, state, or local law.We will consider for employment qualified candidates with arrest and conviction records, consistent with applicable law (including, for example, the San Francisco Fair Chance Ordinance for roles based in San Francisco).