Senior Director, Quality Assurance & Regulatory Affairs-Midwest in Warsaw, IN at Tecomet

Date Posted: 3/11/2018

Job Snapshot

Job Description


Provide overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities in the Midwest region.  Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements, create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations for + $400 million in annual sales. This is accomplished by maintaining Tecomets principles of Safety, Quality, Customer Satisfaction and Innovations.


  • Oversee and implement an advanced level of world-class quality systems for planning, design of experiments (DOE), ISO 13485, quality function development (QFD), design for world-class manufacturability. Take a leadership role as a Sr. Director and mentor supporting functional team members.Integrate the quality function with manufacturing as a value added (real-time) support function, optimizing the continuous quality improvement process, while reducing cost and improving customer relationships.

  • Design and facilitate the development of quality systems for a highly regulated medical device industry to achieve customer satisfaction, increase productivity and maximize the profit margins for Tecomet.The objective is to devise systems that facilitate good products fast without compromise.

  • Assure Tecomet is conducting business within compliance to the regulations, as cost effectively and efficiently as possible.

  • Provide organizational assessments to upper management.

  • Enhance the one company systems interface capabilities, whereas optimizing the capabilities to perpetuate harmonized systems improvements, and based on deploying the best practices from the collective experience contribution of the worldwide teams.

  • Ensure the quality systems focus remains on continual quality improvement, while aligned with internal and external customer expectations. The results/objectives are geared on achieving an error-free (flawless) process, which will deliver products on time with world-class quality standards for improving quality, profits and generating new business.

  • Ensure the organization is basing improvement related decisions on factually/meaningful data, subsequently reducing waste and expediting the recognition of favorable results.

  • Leadership responsibility for promoting and developing Tecomet’s Environment Management System; Worldwide Quality Management Systems Software implementation/validation and harmonization (ETQ); New Product Development; and Worldwide Supplier Quality Systems.


  • Strong organizational skills

  • Strong people and leadership skills

  • Diplomacy
  • Motivation
  • Teaching/Coaching/Mentoring
  • Verbal and written communication and listening skills

  • Problem solving and evaluation

  • Process improvement

  • Computer operation

  • Project management

  • ISO 13485/EN46001

  • ISO 14001

  • Federal and State laws and regulations

  • Knowledge of International Quality Standards

  • Knowledge of International Environmental Standards

  • Strong auditing background

    • Speak in front of people in a variety of settings

    • Be flexible and adapt to changes in the market place

    • Create and manage high performing work teams

    • Interface professionally and courteously with customers/public/internal staff

    • Prioritize work

    • Meet goals and objectives set for company

    • Make decisions in a consistent, professional manner

    • Maximize opportunities for the business


    • Bachelor of Science in Engineering (ME, IE, BME) required

    • Six Sigma Black Belt certification (desirable but not essential)

    • Seven (7) to ten (10) years of quality engineering experience directly I new product development of medical devices is required.

    • Master’s degree (desirable but not essential)


    • Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation.

    • Light physical activity performing non-strenuous daily activities of a primarily administrative nature.

    • Ability to maneuver throughout the facility/facilities as needed.

    • Manual dexterity sufficient to reach/handle items and work with fingers.

    • Ability to wear proper PPE.

TRAVEL REQUIREMENTS:    X   YES          NO                                                           


Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions.  In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all inclusive.  In accordance with Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals.  However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization. Job descriptions are not intended as and do not create employment contracts.  This organization maintains its status as an at-will employer.  Employees can be terminated for any reason not prohibited by law.  Tecomet is an EOE Employer M/W/Vets/Disabled.