Quality Assurance Manager - Lincotek Medical

About the Role:

Manages product assurance program to prevent or eliminate defects in new or existing products by performing the following duties personally or through subordinates. Ensures the promotion of awareness of regulatory and customer requirements throughout the organization.

Is responsible for the tactical operations of the Quality Assurance Department. Insures personnel management is fulfilled and a team core culture is established within the organization and successful collaboration with all manufacturing, finance, supply chain, EHS departments.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Manages all aspects for the company quality system.
• Responsible for and directs 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.
• Responsible and directs document control.
• Manages support staff of QA Engineers, Inspectors, and Auditors.
• Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities.
• Manages 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.
• Responsible for continuous improvement of business processes.
• Evaluates contents of reports from product assurance program department heads and confers with top management personnel preparatory to formulating fiscal budget for product assurance program.
• Conducts management meetings with product design department heads to establish, delineate, and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.
• 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.

SUPERVISORY RESPONSIBILITIES

Directly supervises members of the Quality Department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

High School diploma or G.E.D, Bachelor's Degree in related field required. Prefer a Master's degree (M. A.) or equivalent; or four to ten 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.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to talk or hear. The employee is occasionally required to stand; walk; sit; use hands to handle or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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