The Quality Control Manager is responsible for developing, maintaining and improving QC compliance program. Establishes a continuous improvement culture to ensure systems and processes are developed, maintained and designed to properly support day to day operations. Oversees all Quality Control activities throughout the product lifecycle, from new product development through end-of-life. Responsible for developing the plans and process controls to ensure compliance to regulations, standards and customer requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Establishes and maintains Quality Control System ensuring that design, manufacture and product performance conforms to established company and regulatory standards.
Establish strategic plans to facilitate compliance with domestic and international regulations, including FDA Quality Systems Regulations, ISO 13485, EU MDD, etc.
Partners with R&D, engineering, manufacturing and sales/marketing to ensure quality is designed and manufactured into product.
Possesses the necessary independence, authority and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product.
Establish procedures to ensure that the QC Program will meet or exceed internal and external customer needs and expectations.
Establishes and monitors metrics for the measurement of Quality indicators and quality costs to ensure effectiveness and value to the business.
Interacts with customers and vendors to provide technical support for material concerns/problems and responds to customer information requests.
Serves as the site Management Representative to provide regular reports on the status of the QC Program to management.
Develops and maintains quality control staff through coaching, development and training.
Achieves financial objectives by preparing the quality assurance budget; scheduling expenditures; analyzing variances; initiating corrective and preventive actions.
Ability to establish cause and effect relationships, solve problems, apply scientific methods and optimize processes.
Excellent communication and interpersonal relation skills are required.
Statistical and analytical problem solving skills are required.
The ability to influence at senior levels and across functions building strong networks internally and externally is required.
Strong experience and proven record motivating leading and developing staff, in a highly changing environment is required.
Change management skills are strongly preferred.
Bachelor’s degree in a science discipline
8+ years of quality experience in the medical device industry
5+ years of direct-report people management experience
8+ years of experience with quality compliance, including interpretation and application of QSR and ISO Standards
An ASQ certification (CQE, CQM, CRE or CQA) or equivalent is preferred.
Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred.
5+ years of experience in lean manufacturing and manufacturing processes such as Just in Time (JIT), KANBAN, and Pull Systems is preferred.
TIDI Products is a global manufacturer of single-use medical, dental, film and food service products. We believe our employees and our customer service distinguish us from our competitors. TIDI Products has a strong commitment to its employees, and we are proud of the men and women who make TIDI the company that it is. Our seasoned workforce of engaged, diverse employees is at TIDI’s foundation. T...IDI is committed to producing the best results possible and to provide an atmosphere where our employees can grow with the company and achieve personal success.
TIDI Products offers a competitive salary and benefits package, including a 401(k) with a matching provision, profit sharing, comprehensive group medical, dental, short-term disability, long-term disability, and life insurance. TIDI also offers a vacation package and celebrates ten paid holidays.
As an employee with TIDI Products, you are able to participate in extra incentives such as, thank-you lunches, gift cards for a job well done, service awards, birthday recognition, holiday gifts, appreciation dinner and the annual Children’s Holiday celebration.
It is the policy of TIDI Products, LLC to provide equal employment opportunity to all individuals regardless of their race, creed, color, religion, sex, age, national origin, disabilities, veteran status, marital status, sexual orientation, military status, genetic information, or any other characteristic protected by state or federal law. We are strongly committed to this policy and believe in the concept and spirit of the law.
ASM International is the world's largest association of metals-centric materials engineers and scientists. We are dedicated to informing, educating, and connecting the materials community to solve problems and stimulate innovation around the world.
ASM World Headquarters 9639 Kinsman Road Materials Park, OH 44073-0002