6 Regulatory/Quality Engineer Jobs in Garland, TX
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Galt OEM is Hiring a Regulatory/Quality Engineer Near Garland, TX
Responsibilities
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- 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
- 4-year College or University Degree in Business, Quality, Engineering or related field preferred
- 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
- 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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Job Summary
JOB TYPE
Full Time
SALARY
$86k-102k (estimate)
POST DATE
05/25/2024
EXPIRATION DATE
06/22/2024
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