Regulatory/Quality Engineer

Galt OEM

Garland, TX

Full-Time

Job Description

Regulatory/Quality Engineer
This position reports to the Director Of Quality/RA
Typical Duties and Responsibilities:

Achieves product and engineering compliance by developing and executing compliance programs and completing documentation.
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.

Required Skills and Qualifications

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.
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.
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.
Excellent written and verbal communication skills.
Strong knowledge of relevant software, quality assurance methods, tools and quality manufacturing processes.
Attention to detail.
Ability to handle stress.

It is the policy of Theragenics & Galt not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion or veteran status.

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