- Support new business development Provides support to new business development relating to quality matters as neededDraft preliminary Quality Plan, if appropriateProvides cost and time estimates for anticipated quality department services such as metrology or validation servicesFunctions as a resource for applicable ISO Program and QSR Program requirements
- Support Program Launch and Product Realization as functional department representative assigned to team and Program Manager Reviews new program drawings/information/customer specifications to understand program requirementsDetermines quality and reliability standards and ensures dimensional and cosmetic requirements, as well as customer specifications, are defined and understood.Drafts program Quality Plan (as required) and metrology labor plan to include definition of required fixtures, calibration and metrology requirements and measurement methods needed to meet customer requirements for approvalDrafts other required quality documentation such as Dimensional Visual Quality Requirements (DVQR's) and new product inspection techniquesConfirms customer agreement on GD&T callouts/interpretations and all critical dimensions of program when requiredPrepares Failure Mode Effects Analysis (FMEA), as neededPrepares Traveler DocumentDevelops required Control/Test methodsEnsures First Article Inspection (FAI) and Capability Studies are scheduled and completedCompletes FAI and capability study analysis for submission to customerAuthors operational qualification (OQ) and performance qualification (PQ) protocols and provides training for protocol participantsOversees the execution of assigned OQ and PQ studies to ensure compliance with protocol requirements and completion of study tasksAuthors OQ and PQ Completion Reports to include resolution of any deviations recorded and overall study conclusionEstablishes "golden sample" standards and prepares and submits to customer via customer approval form (CAF) as requiredAttends program team meetings to address quality-related mattersPerforms assigned activities in a timely manner
- Provide continuous quality engineering support through program end of life. Completes Certificates of Conformance (CoC) for outgoing products, where requiredCollects and analyzes production line data to monitor yield and defect performanceEnsures golden samples are retained and controlledMaintains Device History Records (DHR) as necessaryPerforms periodic risk assessments, as requiredAssists Purchasing Department with maintaining vendor quality requirementsContinuously monitors production to identify quality-related customer issues and supports corrective action plans when necessaryIssue or authorize CCR's as needed. Manages the return of goods, assignments and close out of RC/CA.Conducts root cause investigation and develops corrective action plans for assigned problem reports (PSRs) and quality issuesManages product and process change control and notification to ensure required Engineering Change Orders (ECOs) are generated and approved by the customer prior to implementation.Attends program team meetings as necessary to resolve program quality issues to maintain customer satisfactionSupport QBR's with customer and provides/presents quality-related topicsParticipates in customer, certified body, and regulatory audits as a subject matter expert for assigned products and processes
- Occasional domestic travel required
- Meets or exceeds yearly assigned goals
- Has a working knowledge of Statistical techniques and sampling plans and of Quality Systems Regulations and ISO Standards
- Other duties as assigned
- Analytical – Collects and researches data; Uses intuition and experience to complement data.
- Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.
- Customer Service – Manages difficult or emotional customer situations; Responds promptly to customer needs; Responds to requests for service and assistance; Meets commitments.
- Interpersonal – Listens to others without interrupting; Remains open to others' ideas and tries new things. Behaves in a respectful and professional manner.
- Oral Communication – Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions.
- Written Communication – Writes clearly and informatively; Presents numerical data effectively; Able to read and interpret written information.
- Quality Management – Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
- Ethics – Works with integrity and ethically; Upholds organizational values.
- Organizational Support – Follows policies and procedures; Completes administrative tasks correctly and on time; Manages competing demands; Able to deal with frequent change, delays, or unexpected events.
- Judgment – Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process.
- Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently.
- Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Monitors own work to ensure quality.
- Safety and Security – Observes safety and security procedures; Uses equipment and materials responsibly.
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Description
Reports To: Quality Engineering Manager
Department: Quality
Division: Northern
Location: Headquarters, Arlington or Cavendish Plant
Summary: Provides quality engineering support during new business development, new program launches and for existing customer programs
Essential Duties and Responsibilities:
Competency : To perform the job successfully, an individual should demonstrate the following competencies:
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/Experience: Bachelor's degree (B.S.) in a technical (STEM or Engineering) field preferred, plus zero to two years related experience. Minimum education requirements are a H.S. diploma with 1 or more years of related quality experience. Experience in a 21CFR Part 820 or ISO 13485 quality system environment strongly preferred. Experience with Six Sigma or Lean manufacturing techniques preferred.
Language Ability: 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.
Math Ability: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to apply concepts such as fractions, percentages, ratios, and to draw and interpret bar graphs.
Reasoning Ability: Ability to interpret a variety of technical instructions furnished in written, oral, mathematical, diagram, or schedule form and deal with abstract and concrete variables. Ability to define problems, collect data, establish facts, and draw valid conclusions.
Computer Skills: To perform this job successfully, an individual should have knowledge of, and strong working familiarity with, Microsoft Word, Access and Excel in a Windows environment. Project Management software, statistical software and Manufacturing software experience preferred.
Licenses and Certifications: There are no certifications required for this position.
Supervisory Responsibilities : This job has no supervisory responsibilities.
Work Environment: The work environment characteristics described herein 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.
While performing the duties of this job, the employee occasionally works near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles and toxic chemicals.
The noise level in the work environment is usually moderate, occasionally loud.
Physical Demands: The physical demands described herein 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 use hands to finger, handle, or feel. The employee is frequently required to stand; walk; sit; reach with hands and arms and talk and hear. 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 the ability to adjust focus.
