PD Quality Engineer Senior Staff

Job Description:

SUMMARY: The PD (Process Development) Quality Engineer Senior Staff works on problems and projects of moderate to complex scope where analysis of situation or data requires a review of identifiable factors, knowledge of industry regulations and best practices, and critical thinking skills. Participate in decisions on scope of work, selection of materials/equipment/test methodology, definition of processing steps and inspections, and length of tasks. Participate in decisions to recommend design changes to customers when necessary. Participate in the definition and documentation of Product/Process Risk Management, Process Validation and Test Method Validation.

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

• Responsible as part of a cross-functional team for developing, applying, revising and maintaining quality and regulatory standards for designing and processing materials/products into partially or finished medical device products.
• Implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
• Diagnose and resolve manufacturing and quality system issues.
• Participate in performing design, optimization, validation and production readiness reviews, to ensure the safe and environmentally sound start-up of new processes.
• Generate and maintain risk management files supporting product and process development, such as Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, Post Market Surveillance plans and other related documents.
• Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance Interval Analysis, ANOVA.
• Support Product/Process Development Engineering in Optimization activities by guiding Design of Experiments of various process parameters and analyzing data.
• Write Process Validation and Test Method Validation Protocols, analyze data and write and release validation reports.
• Creates Test Methods for new processes, including protocols, reports and execution.
• Establishes manufacturing controls base on drawings or product specifications.
• Communicate with Customer as needed on Process Development Responsibilities, Quality Issues and/or Supplier Initiated Change Requests.
• Support Hosting of External Customer and or Notified Body Audits as applicable.
• Investigate and manage customer field complaints, SCAR’s and internal CAPA’s as needed.
• Represent Quality Assurance for Non-Conformance Report dispositions, and participate in monthly Oversight Review Boards as needed.
• Provide training on quality system procedures and industry regulations/best practices.
• Interface with customers and suppliers as needed for quality issues and project requirements.
• Follows all safety and production standard operating procedures.
• Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for product safety and compliance.
• Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
  
  

SUPERVISORY RESPONSIBILITIES:

Have supervisory responsibilities: No

Leadership: N/A

Supervises: N/A

Supervision:

General Direction: receive very general guidance with respect to overall objectives; work is usually carried out in a teamwork environment with interdisciplinary internal and external teams; operate within division or department policy guidelines using independent judgment in achieving assigned objectives.

EDUCATION and/or EXPERIENCE: Bachelor degree in a related engineering discipline; 6-8 years of related experience working in Quality in a medical device environment. Master degree is a plus. 4 years or more of experience in Medical Device Product Development, 5 or more years of experience with FDA, ISO 13485 and EU MDR Design Control requirements. Demonstrated knowledge of and practical application of ISO 14971 and IEC 62366 requirements. Strong statistical data analysis skills using Minitab. Competent in Microsoft Office applications.

OTHER SKILLS and ABILITIES: Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of relates specialties. Experience and knowledge in Process Development and Process Validation in the Medical Device Industry would be an important asset.

Provides leadership to others through example and sharing of knowledge/skills.

Customer service, quality focus, problem solving, market knowledge, documentation skills, confidentiality, analyzing information, multi-tasking, and project management skills.

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to write speeches and articles for publication that conforms to prescribed style and format. Ability to effectively present information to public groups among the natural working team, customers, regulatory members or business community.

Ability to define priorities and communicate correctly risks, results of investigations and technical data. Able to work in interdisciplinary teams and provide guidance about regulations and internal/external standards and/or procedures.

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.

Ability to define problems, collects data, establishes 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.

Proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, ERP systems, 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:

Lifting or carrying items.

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

PHYSICAL ACTIVITY LEVEL: Moderate physical activity moving around the manufacturing process and offices areas, as well as performing somewhat strenuous daily activities of a primarily administrative nature.

COMMENTS: This position 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.