Quality Engineering Manager

Job Description:

SUMMARY: Provides vision, leadership, coaching and mentoring to organization, with focus in regulatory compliance and quality assurance. Works on problems and projects of moderate scope where analysis of situation or data requires a review of identifiable factors. Participates in decisions on scope of work, selection of equipment and length of tasks. Decides on design changes to meet revised specifications. Provides and develops solutions to problems of limited scope. Must be able to accomplish broad and complex assignments. May provide technical guidance to lower personnel. Identifies and provides resources needed for the Quality Department to accomplish company and site goals.

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Carries vision from senior staff to subordinate staff.
• Develops department measures.
• Develops department budgets, both operating and capital. Participates and compiles statistics in the preparation and control of department operating budgets.
• Responsible for developing, applying, revising, and maintaining quality standards for processing materials/products into partially or finished products.
• Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
• Analyzes reports and returned products and recommends corrective action.
• Prepares documentation for inspection/testing procedures.
• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
• Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.
• Devises new approaches to problems encountered.
• Independently performs most assignments with instructions as to the general results expected.
• Receives technical guidance on unusual or complex problems and supervisory approval on proposed plan for projects.
• Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project or in a total project of moderate scope.
• Performs work which involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements.
• Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of relates specialties.
• Responsible for ensuring personal and company compliance with Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Responsible for the purchase or design of equipment that meets health, safety, and environmental standards set by the company.
• Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
• May technically supervise or coordinate the work of engineers, draftspersons, technicians, and others who assist in specific assignments.
• Practices company safety, quality policies and procedures, actively requires conformance.
  
  

SUPERVISORY RESPONSIBILITIES:

Have supervisory responsibilities: Yes

Leadership: Supervise/manage/direct the selection, training, development, appraisal and work assignments of personnel.

Supervises:

• Quality Assurance Engineer I, II, Sr. Staff
• Quality Control Supervisor II, III
• Quality Assurance Technician
  
  

Supervision:

Nominal Direction: subject only to very broad communication associated with my position.

EDUCATION and/or EXPERIENCE: Bachelor degree in a related engineering discipline, advanced degree preferred; 6-7 years of related experience. Experience in the medical device industry would be an asset. Certification and/or license in specific discipline would be an asset. Certified Quality Engineer would be an asset. ISO 13485 Lead Auditor or equivalent and Six Sigma Black Belt Certification, Certified Quality Engineer or equivalent.

OTHER SKILLS and ABILITIES: Must possess more than a basic understanding of engineering theoretical fundamentals and experimental techniques. Individuals at this level should be developing skills related to conflicting design requirements, unsuitability of conventional materials and difficult coordination requirements. English communication skills, written and oral.

Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors.

Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory. Ability to work with concepts such as limits, rings, quadratic and differential equations, and proofs of theorems.

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

Demonstrated use of intermediate computer operations (basic programming in 3rd and 4th generation languages, relational databases, and operating systems) and intermediate software packages, word processing, spreadsheet, graphics, etc.)

MANUAL DEXTERITY: Manual dexterity sufficient to reach/handle items and work with the fingers.

VISION REQUIREMENTS: No special vision requirements

WORK SCHEDULE/HOURS: Monday – Friday.

TRAVEL: Minimal

ENVIRONMENTAL WORKING CONDITIONS: Well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation.

PHYSICAL DEMANDS

Other physical working conditions:

Moderate noise (examples: business office with computers and printers, light traffic)

PHYSICAL ACTIVITY LEVEL:

Sedentary physical activity performing non-strenuous daily activities of an administrative nature.

COMMENTS: This job description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.