Job Description: Summary
The Staff Quality engineer is responsible for ensuring TTM products are developed and released meeting customer expectation, regulatory requirements, appropriate voluntary standards, and BD policies and procedures. You will work as a member of a TTM cross-functional project team engaged in ongoing Product Life Cycle technical support. Will serve as a quality representative on project core teams and will work closely with R&D, Operations, Regulatory Affairs, Marketing and Distribution.
This position requires a self-directed individual able to handle multiple projects and tasks utilizing a high level of written and oral communication skills. In addition the incumbent may be expected to initiate quality initiative projects, become thoroughly knowledgeable with all aspects of Sustaining Engineering and/or New Product Development projects, and assume personal responsibility for the successful completion of all tasks within the realm of Quality Engineering responsibilities.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Represents the Corporation, Division and Quality Department in a professional manner.
Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
Provides Quality Assurance leadership for Project Teams or Quality Department.
Creates, reviews and approves Quality System Documents (CAPA, Audits)
Creates, reviews and approves Product Documents, such as Design History Files
Creates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols, Software Validation documents
Creates reviews and approves Risk Management Files documents such as: Risk Management Report, Hazard Analysis, Risk Benefit Analysis and FMEA's
Provides supervision to technicians and engineers
Analyzes process and product non-conformance's and implement comprehensive corrective and preventive action plans.
Performs Internal or Supplier Quality System Audits.
Ensures compliance to Department and Division procedures.
Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.
Perform failure investigations and implement comprehensive corrective and preventive action plans using methodologies as Six Sigma/Lean Six Sigma
Interfaces with manufacturing facility or other Division Facilities.
To perform this job successful, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and 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.
Ability to perform engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems.
Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information.
Comprehensive knowledge of quality systems and relationship to business.
Experience in electromechanical devices, Deep understanding of compliance standards IEC 60601-1 and reliability engineering
Comprehensive knowledge of Design Control Processes for medical devices
Has experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.
Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi.
Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies.
Broad knowledge of manufacturing processes.
Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
Understands Fundamentals of Engineering Principles.
Ability to effectively manage time.
Ability to handle multiple task assignments.
Ability to translate quality requirements into product specifications.
Ability to interpret Regulations, Corporate, Division and Department Procedures.
EDUCATION and/or EXPERIENCE
B.S. in Engineering, Engineering Technology, Science a minimum.
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.)
Experience with electromechanical Devices
Minimum 7 years of experience with FDA regulated industry including three years on product development programs.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Well-versed in statistics, modeling, optimization, data presentation and analysis and application to business problems.
Basic Applied Statistics, Statistical Sampling Plans, Statistical process control.
Highly variable operations performed daily from complex regulatory and engineering decisions to routine administrative functions. Interpretation of regulations (GMP, ISO 13485, ISO 14971, IEC 60601) into standards and procedures as required. The ability to explain these interpretations to Plant, Division, Corporate and representatives of Regulatory bodies is necessary.
As a senior engineer, tasks and responsibility are highly complex and very difficult. Considering a few important facts must make judgment for very complex issues; written rules, precedents and policies are available for guiding decisions, but are not always easily attained. Some facts may be difficult to attain and the relationship between facts difficult to establish. There are often instances where quick judgments must be made that can have significant impact to the Company. Individual is looked upon as a decision-resource person, one of high integrity and decision-making skills.
A great deal of work must be initiated through a detailed knowledge and understanding of the job function, the establishment of plans to attain the end goal. There is a great deal of freedom of action, originality and imaginative drive and critical analysis since there is not strict day-to-day supervision. The success of implementation of quality plans is largely dependent upon the person's ability to recognize the most efficient, cost-effective approach to attaining the desired goal. In many instances, the person will be required to use creativity and imagination in carrying out the job function. This person will be working in a fast-paced, technically challenging environment where drive is critical to success.
Decisions made by this person could have significant regulatory and financial implications. Furthermore, this person's decisions could have a significant impact on health care practitioners and the welfare of their patients.
Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position works in a normal office environment. The noise level in the work environment is quiet to moderate.
Frequent travel is required. When traveling to clinical sites or hospitals, the work environment will be specific to the area under evaluation.
Primary Work Location
USA CO - Louisville
BD (Becton, Dickinson And Company)