Regulatory/Quality Engineer

4 weeks ago

Garland, United States Galt OEM Full time
Job DescriptionJob DescriptionRESPONSIBILITIES
  • Prevents compliance issues by collaborating with engineering planning and design teams, reviewing design data, and developing compliance policies.
  • Identifies and resolves product and engineering design issues by identifying short-term and long-range issues.
  • Researches and identifies applicable regulatory and industry compliance standards and codes.
  • Develops compliance plans by researching, analyzing, selecting, and applying compliance engineering concepts, approaches, techniques, and criteria.
  • Adapts and modifies compliance engineering options.
  • Develops and evaluates new compliance methodologies.
  • Organizes compliance programs by preparing timetables, cost estimates, and required resources, including test laboratories and equipment.
  • Research and contracts with, and supervises, sub-contractors.
  • Determines compliance by establishing compliance test standards, conducting and witnessing tests, performing diagnostic procedures, measuring performance, analyzing and evaluating findings, and performing forensic analysis and troubleshooting of failures.
  • Attains compliance by isolating and resolving compliance issues, recommending product and process changes, and initiating engineering change orders.
  • Documents compliance by completing approval applications, recording test results, preparing investigative reports, preparing, and filing Declarations of Conformity, and maintaining compliance database.
  • Maintains engineering team accomplishments by reviewing open issues and action items, coordinating actions, and contributing information and analysis to team meetings and reports.
  • Prepares compliance reports by collecting, analyzing, and summarizing measurement data and trends.
  • Updates job knowledge by tracking and understanding emerging compliance engineering practices and standards, participating in educational opportunities and professional organizations, reading professional publications, and maintaining personal networks.
  • Enhances engineering and organization reputation by accepting ownership for accomplishing new requests and exploring opportunities to add value to job accomplishments.
  • Implements product testing and process analysis.
  • Creates and maintains post market files for each product family.
  • Generates and maintains technical specifications for each product family by SKU.
  • Assists in Customer and Marketing requests for documentation.
  • Assists in clinical evaluations for each product.
  • Ensure compliance with all regulations.
  • Maintains regulatory documentation database.
  • Keeps up to date with changes in regulatory legislations and guidelines.
  • Perform inspections to ensure compliance with local, state and federal regulations.
  • Develops and evaluates new compliance methodologies.
  • Identifies and interprets relevant regulatory guidelines.
  • Recommends adjudication of product complaints.
  • Completes final acceptance activities. Manges the sterilization process, including validations and product sterile loads.
  • Track nonconforming material. Interfaces and take lead QA role in interactions with suppliers, contractors and consultants that supply components and contract processing.
  • Manages corrective action and quality improvement activities.
  • Assist in the performance of quality system internal auditing. Supports management review meetings. Establishes, monitors and evaluates quality system metrics.
  • Other ad-hoc duties as assigned.

REQUIREMENTS

EDUCATION: 
  • 4-year College or University Degree in Business, Quality, Engineering or related field preferred.
EXPERIENCE:
  • 2-3 years’ experience in a Quality related role, preferably in the Medical industry.
  • Proven leadership, interpersonal skills and personal development skills.
  • Experience in a variety of basic operation disciplines: Manufacturing, Quality Process/Tooling and Shop Floor Supervision.
  • Proficient in Microsoft Office.
  • Strong knowledge of relevant software, quality assurance methods, tools and quality manufacturing processes.
POSITION SKILLS:
  • Ability to solve complex problems and exercise judgement based on the analysis of multiples sources of information.
  • Ability to read and interpret engineering drawings and specifications.
  • Ability to support and/or lead root cause analysis, disciplined problem-solving and decision-making processes.
  • Analysis and critical thinking.
  • Excellent written and verbal communication skills.
  • Attention to detail.
  • Ability to handle stress.

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