Quality Engineer - Lincotek Medical

About the Role:

Plans and oversees activities for product assurance program to prevent or eliminate defects in new or existing products by performing the following duties personally or with collaboration with other employees. Ensures the promotion of awareness of regulatory and customer requirements throughout the organization.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Develops and implements aspects for the company quality system.
• Works to improve and control regulatory/ISO compliance.
• Analyzes, evaluates, and presents information concerning factors, such as business situations, production capabilities, manufacturing problems, economic trends, and design and development of new and existing products.
• Develops document control.
• Suggests alternative methods and procedures in solving problems and meeting changing market opportunities.
• Establishes QA processes and is responsible for inspection of manufactured parts.
• Develops initial and subsequent modifications of product designs to delineate areas of responsibility, personnel requirements, and operational procedures within program, according to and consistent with company goals and policies.
• Devises sampling procedures and controls for continuous improvement of business processes.
• Evaluates contents of product assurance programs and confers with personnel preparatory to formulating product assurance program.
• Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders, and vendor quality standards.
• Confers with engineers about quality assurance of new products designed and manufactured products on market to rectify problems.
• Compiles and writes training material and conducts training sessions on quality control activities.
• Develops and implements methods and procedures for disposition of discrepant material, and devises methods to assess cost and responsibility.
• Works overtime as needed.
• Other responsibilities, as assigned

EDUCATION and/or EXPERIENCE

High School Diploma or G.E.D. and bachelor's degree in related field required. Prefer a master's degree (M. A.) or equivalent; or more than three years' related experience and/or training; or equivalent combination of education and experience.

LANGUAGE SKILLS

Excellent communication skills. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.

Benefits Include: Medical, Dental, Vision, FSA, HSA, Life Insurance, PTO, Paid Holidays, 401k, EAP

Lincotek Medical provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

Employment is contingent upon successfully passing both Background and Drug Pre-Employment Screenings