Production Specialist

Kimball Electronics; Indianapolis (IN); On-site; USD 52,000 - 76,000; Full time

Benefits offered by this job

PTO 3 weeks and holidays

Shift premium $1.75 (3rd shift)

Health, dental, vision insurance

401(k) with match

Disability and life insurance

Job summary

Kimball Electronics is hiring a Production Specialist to support operations in medical device manufacturing. You will train, direct and supervise production associates, ensure quality products, and follow Good Documentation Practices.

The role reports to a Production Supervisor within Operations, with a focus on continuous improvement, 6S, and adherence to ISO 13485 and FDA GMP. This is a 3rd shift position with shift premium and comprehensive benefits starting day 1.

Qualifications

• Medical manufacturing experience preferred.
• Ability to communicate effectively (verbal, written, documentation).
• Experience with MS Office and comfortable with different computer programs.
• Self-motivated, organized, exhibit willingness to change under pressure.
• Able to review procedures and interpret assembly drawings.

Responsibilities

• Assist supervisor to oversee area staff and ensure quality products are manufactured efficiently.
• Verify batch record documentation per procedures and Good Documentation Practices.
• Lead and be accountable for team results.
• Support continuous improvement and 6S initiatives in area of responsibility.

Skills

MS Office

Documentation

Root Cause Analysis

Continuous Improvement

Team Leadership

Tools

ERP system

Quality systems

Job description

We are committed to providing reasonable accommodations for individuals with disabilities in our job application process. If you need assistance or an accommodation during the application or recruitment process due to a disability, you may contact us at [e-mail]. We will treat all requests for accommodations discreetly. *Note: There is no Visa sponsorship being offered for this position. Kimball Electronics does not accept agency resumes. Please do not forward resumes to any recruiting alias or employee. Kimball Electronics is not responsible for any fees related to unsolicited resumes. 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.

3rd Shift: 11p-7a, Sunday-Thursday. Shift Premium $1.75

Position Overview

The 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 Summary

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.

Basic Background Requirements

• Medical manufacturing experience is preferred
• Ability to work on pharmaceutical products with the end patient in mind
• Ability to Communicate effectively (verbal, written, documentation)
• Experience with MS Office and comfortable working with different computer programs
• Must 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 team
• The ability to work with all levels of the organization
• React 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 requirements
• Works overtime as required to provide excellent customer satisfaction
• Operate 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 Regulation

Key Performance Objectives

Short Term: (0 to 3 months)

• Learn and adopt Kimball Electronics philosophies and culture
• Learn KEIND Quality system requirements
• Learn Good Documentation Practices
• Complete inventory forms as required
• Build relationships with Operations, Quality and Material Handling team members
• Maintain 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 area

Midterm: (3 to 6 month)

• Ability to review procedures for accuracy.
• Provide improvement ideas for review & drive implementation
• Report production in the ERP system and on Work Order documentation
• Lead and be accountable for team and their results

Long term: (6 to 12 months)

• Improve procedures and Processes for production efficiency.
• Provide training for other production specialists
• Initiate and complete Engineer Change Orders
• Complete 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).

WHO WE ARE

Kimball Solutions was founded in 1961. We have established ourselves as a global leader in delivering durable electronics and offering contract manufacturing services for a wide range of industries. Our operations are supported by a robust Customer Relationship Management (CRM) model, which provides our customers with convenient access to our global footprint and services throughout the entire product life cycle. We are recognized for our commitment to quality, international standard certifications, financial stability, social responsibility, and long-term relationships, especially in industries that demand rigorous engineering controls and long product life cycles.

WHAT WE DO

• Production and testing of printed circuit board assemblies (PCBAs)
• High-level and final assembly of medical, automotive, and industrial products
• Design services and support
• Supply chain services and support
• Rapid prototyping and new product introduction support
• Product design and process validation and qualification
• Industrialization and automation of manufacturing processes
• Reliability testing (extreme environmental conditions)
• Aftermarket services
• Production and assembly of medical devices, medical disposables, and other non-electronic products
• Drug delivery devices and solutions with and without electronics
• Class 7 and 8 clean room assembly, cold chain, and product sterilization management
• Design engineering and production of precision molded plastics
• Complete product life cycle management

Our Package of Value

Our package of value begins with our core competency of producing durable electronics by providing Electronics Manufacturing Services (EMS), complemented by contract manufacturing services by our Contract Manufacturing Organization (CMO) for medical disposables, drug delivery solutions, and precision molded plastics. We combine our design and manufacturing expertise with highly integrated processes and procedures to deliver the highest levels of quality and reliability throughout the entire life cycle of our customers’ products. Our award-winning service, global operations platform, and dedication to standardization and teamwork ensure that we consistently meet and exceed our customers' expectations.