Quality Engineer Medical Devices

Quality Engineer- Medical Devices

Reports To: Quality Assurance Manager

Department: Quality

Division: Northern Division

Location: Headquarters

Summary:
Provides quality engineering support during new business development program launches and for existing customers. The Quality Engineer will ensure that manufacturing processes quality systems and finished products for medical devices meet all applicable regulatory customer and internal quality requirements.

• This role involves working in anITAR-controlled environment. The successful candidate will have a strong technical background problem-solving skills and the ability to work within the strict compliance requirements of ITAR regulations.

Essential Duties and Responsibilities:

• Support new business development
  • Provides support to new business development relating to quality matters as needed.
  • Draft preliminary Quality Plan if appropriate.
  • Provides cost and time estimates for anticipated quality department services such as metrology or validation services.
  • Functions as a resource for CFR Part 820 and ISO 13485 regulatory 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 requirements.
  • Support customer audits regulatory inspections and certification.
  • Drafts program Quality Plan PFMEA and Dynamic Control Plans as required.
  • Drafts other required quality documentation such as Dimensional Visual Quality Requirements (DVQRs) and new product inspection techniques.
  • Confirms customer agreement on GD&T callouts/interpretations and all critical dimensions of program when required.
  • Prepares manufacturing job travelers and associated process documents.
  • Develops required Control/Test methods.
  • Ensures First Article Inspection (FAI) and Capability Studies are scheduled and completed.
  • Completes FAI and capability study analysis for submission to customer.
  • Generates validation plans operational qualification (OQ) performance qualification (PQ) protocols and provides training for protocol participants.
  • Oversees the execution of assigned validation activities to ensure compliance with protocol requirements and completion of study tasks.
  • Generates Required validation completion reports to include resolution of any deviations recorded and overall study conclusion.
  • Perform first-piece and in-process approvals for new setups tooling changes or process adjustments.
  • Attends program team meetings to support production-related matters.
  • Performs 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 required.
  • Collects and analyzes production line data to monitor yield and defect performance.
  • Use statistical tools (SPC DOE capability studies) to identify process improvement opportunities.
  • Maintains Device Master Records including Device History Records as required.
  • Performs periodic risk assessments as required.
  • Assists Purchasing Department with maintaining vendor quality requirements.
  • Continuously monitors production to identify quality-related customer issues and supports corrective action plans when necessary.
  • Issue or authorize customer complaints and returns as needed. Manages the return of goods assignments and close out of RC/CA.
  • Documents nonconformances conducts thorough root cause analyses and develops and implements effective corrective action plans.
  • Manages 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 satisfaction.
  • Support quality business reviews with customer and provides/presents quality-related topics.
  • Participates in customer certified body and regulatory audits as a subject matter expert for assigned products and processes.

Has a working knowledge of:

• Statistical techniques and tools (Minitab) and sampling plans.
• Strong analytical and root cause problem-solving skills (5-Whys Fishbone 8D).
• Quality Systems Regulations and ISO Standards.
• Advanced Product Quality Planning (APQP)
• Multiple manufacturing processes (e.g. injection molding machining assembly packaging).
• Occasional domestic travel required.
• Other duties as assigned.

Competency:

To perform the job successfully an individual should demonstrate the following competencies:

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.

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:

Bachelors degree (B.S.) in a technical (STEM or Engineering) field preferred plus one or more years related experience. Minimum education requirements are a H.S. diploma with three 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.

Communication Skills:

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.

Mathematical & Analytical Skills:

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.

Critical Thinking & Problem-Solving:

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.

Technical & Computer Proficiency:

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:

Preference may be given to an individual with an ASQ Quality Engineering certification.

Supervisory Responsibilities:

This job may include supervisory responsibilities for a Quality Technician.

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.

Required Experience:

Manager