Manufacturing Compliance Manager

 •  Intermec Louisville, KY

Less than 5 years experience  •  Manufacturing / Diversified

Salary depends on experience
Posted on 08/11/17
Louisville, KY
Less than 5 years experience
Manufacturing / Diversified
Salary depends on experience
Posted on 08/11/17

Honeywell Life Care Solutions provides digital health technologies for health care systems, payors, employers, home health agencies, and individuals to improve the quality and cost efficiency of care.

Our mission is to accurately assess people’s health, over time, in the environments where they live, work, and play so they can live more productive lives.

Through our state-of-the-art medical monitoring equipment, technological support, and industry expertise, we provide individuals and the clinicians treating them with easy-to-use, cost efficient remote monitoring solutions.

Life Care Solutions is seeking an experienced Manufacturing Compliance Manager to work in our Louisville, KY Production and Service/Repairs Department.

As a highly-motivated, top-notch candidate you will have an opportunity to showcase your expertise in production quality assurance and compliance, cross functional leadership, process improvement and performance planning.

RESPONSIBILITIES

  • Plan, execute and summarize design transfer activities (production and service/repair) as the manufacturing representative on the cross functional program team.

  • Plan, implement, conduct and remediate annual audits for compliance to international recognized manufacturing standards and guidelines.

  • Work closely with production associates, service/repair technicians and the business leadership team to build a culture of quality, compliance and continuous improvement.

  • Drive corrective and preventative action plans around defects or potential defects related to the manufacturing and repair processes.

  • Provide leadership, coaching, mentoring and training around process compliance, continuous improvement, inventory management, standard workflows and good manufacturing practices.

  • Implement training plans and materials, while maintaining compliance to specified training intervals.

  • Continuous personal development

  • Up to 25% travel

MUST HAVE:

  • Bachelor’s degree in a technical field or a minimum of 7 years of relevant job experience.

  • Minimum of 3 years of work experience in a regulated industry

WE VALUE:

  • A portion of work experience to preferably include 21 CFR 820 and ISO 13485.

  • Experience working for a medical device manufacturer in the areas of manufacturing, production or quality assurance.

  • Experience creating, maintaining, improving and ensuring compliance to production and repair standard work instructions.

  • Experience using Six-Sigma, lean manufacturing and Kaizen events to drive continuous improvement in manufacturing/production processes, inventory management and material flow.

  • Experience as a cross functional team member, representing service, repair, production or manufacturing.

  • Experience planning, conducting and facilitating audits for compliance to a regulated entity.

  • Address and resolve production problems related to product design and supplier components using systematic problem solving techniques such as 5 Why, FMEA or FTA.

  • A proven ability to maintain key relationships with engineering, quality, sourcing, and external vendors.

  • A history of self-direction, strong work ethics, strong personal values and driven.

  • Strong computer skills in Microsoft Office applications with a desire for experience using sales force.

LOCATION

Must work in the Louisville, KY facility

ADDITIONAL INFORMATION

  • Job ID: 00355528
  • Category: Business Management
  • Location: Louisville, KY USA

Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.

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