JOB SUMMARY: 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. KNOWLEDGE/SKILLS/ABILITIES: 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. MINIMUM QUALIFICATIONS: Bachelor's degree in a science discipline8+ years of quality experience in the medical device industry5+ years of direct-report people management experience8+ years of experience with quality compliance, including interpretation and application of QSR and ISO Standards PREFERRED QUALIFICATIONS: 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 DISCLAIMER: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.TIDI Products, LLC is an Equal Opportunity employer committed to the principles of diversity. We actively seek applications from veterans, women, persons of color and persons with disabilities.
TIDI Products is an Equal Opportunity Employer - Minorities/Females/Veterans/Disabled are encouraged to apply