TITLE : Quality Assurance and Regulatory Affairs Manager

Department: Quality Assurance / Regulatory Affairs

Classification: Exempt

Reports To: Senior Director QARA or EVP of QARA

Date: 14 July 2022

JOB SUMMARY:

The Quality and Regulatory Manager will 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 + $40 million in annual sales. The role requires the above to be accomplished within Tecomet principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.

ESSENTIAL FUNCTIONS:

• 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. Manager 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.

• Performs other duties or special projects as required or as assigned by supervisor.

KNOWLEDGE, SKILLS AND ABILITIES:

• Add responsibilities here

• Strong organizational skills

• Strong people and leadership skills

• Diplomacy

• Motivation

• Teaching/Coaching/Mentoring

• Verbal and written communication and listening skills

• Highly Proficient in Microsoft Office

• Problem solving and evaluation

• Process improvement

• 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 marketplace

• Create and manage high performing work teams

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

• Prioritize work

• Meet goals and objectives set for the company

• Make decisions in a consistent, professional manner

• Maximize opportunities for the business

EDUCATION AND WORK EXPERIENCE:

Educational/Training Requirement:

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

• Experience, training and certification may be considered

• Master’s degree (desirable but not essential)

Experience:

• 5+ years of Quality Engineering experience within a manufacturing environment required.

• Minimum of 2 years of experience related to working within a regulated environment is preferred.

• 3-5 years working directly with New Product Development and/or related launches, preferred.

Licenses/Certifications:

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

• ASQ: CBA, CQA and CQE certification, preferred.

PHYSICAL AND ENVIRONMENTAL DEMANDS:

• Mobility to move throughout the production facilities and various sites, and to sit for eight (8) or more hours per day.

• Able to communicate quickly and clearly verbally, in writing and by phone.

• Able to perform repetitive, highly accurate keyboard operations for eight(8) or more hours per day and on weekends (if required)

• Ability to read fine print

• Position takes place in a well-lighted, heated/air-conditioned indoor office/production setting with adequate ventilation

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

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

• Ability to wear proper PPE.

Americans with Disabilities Act (ADA):

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity/Affirmative Action Employer/Protected/ Veterans/Disabilities/Drug Free Workplace

TRAVEL REQUIREMENTS: X YES NO

• Travel will be determined as needed.

INTENT AND FUNCTION OF JOB DESCRIPTIONS:

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 Equal Opportunity Employer M/W/Vet/Disabled

Received _Date_

(Employee Name)