Job Details

TITLE : Quality Assurance & Regulatory Affairs Manager

Department: Quality

Classification: Exempt

Reports To: Sr. Dir. Quality Assurance/Regulatory Affairs

Date: May 22, 2017

JOB SUMMARY:

The Quality Assurance & Regulatory Affairs Manager provides overall company leadership and direction to meet customer quality requirements, create, monitor and improve quality programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by maintaining Tecomet's principles of Safety, Quality and Customer Satisfaction.

ESSENTIAL FUNCTIONS:

• Promote and develop plans with Tecomet's customers to certify Tecomet as a preferred supplier.

• Assure consistent controls in the manufacturing process for continuous quality improvement and the reduction of quality costs.

• Optimize manufacturing process run time by identifying and eliminating production failures. Participate in Material Review Board process.

• Coach and train Quality Engineers and Quality Inspectors.

• Internal & external audits/supplier approvals.

• Develop global Quality and Manufacturing standard operating procedures and related improvement plans.

• Measure the effectiveness of the systems in place, report back to upper management and develop. assessments and corrective action plans.

• Oversee/facilitate Design and Development quality & regulatory requirements, which encompass all of design control, Medical Device Listings with the FDA and other affected international governments, vigilance/medical device reporting, Declarations of Conformity.

• Oversee special processes validations and gage control.

• Device pre-sterile packaging and sterilization requirements.

• Records retention/archives management.

• Project a positive and professional image of the company and of management to employees at all levels.

• Responsible to handle human resource responsibilities in a fair, consistent, unbiased, confidential and positive manner while abiding by all laws, policies and procedures.

• Additional functions and requirements may be assigned by manager as deemed appropriate.

• Responsible for timely performance reviews.

KNOWLEDGE, SKILLS AND ABILITIES:

• Strong background in the medical device industry.

• Possesses strong knowledge in manufacturing operations.

• Knowledge of and Responsible for the quality standards within the company.

• Lean manufacturing.

• Promotes 5S within his department and throughout the company.

• Supports the customer focused team environment.

• Knowledge of Tecomet's business systems and the impact on business.

• Possesses knowledge of all applicable domestic and international medical device industry requirements.

• Ability to apply advanced mathematical concepts and apply mathematical operations to determine such tasks as test reliability and validity, correlation techniques and factor analysis.

• Ability to read, analyze, and interpret complex documents such as financial, quality and production reports.

• Ability to respond effectively to sensitive inquiries or complaints.

• Ability to multi-task and prioritize work.

• Is able to communicate at all levels of the organization.

• Is flexible and is able to adapt to changes in the market place.

• Create and manage high performing work teams.

• Identify and make process improvements.

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

• Meet goals and objectives set for department and company.

• Keep current in changing work methods and regulatory changes.

• Make decisions in a consistent, professional manner.

• Maximize opportunities for the business.

EDUCATION AND WORK EXPERIENCE:

• Bachelor's degree (B.A.) from four year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience.

• 3 years manufacturing experience.

PHYSICAL AND ENVIRONMENTAL DEMANDS:

• 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

** Moderate overnight travel up to 30%

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.