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At Phothera we are on a mission to make people safer, healthier, and more productive utilizing phototherapy. Auto-immune skin diseases can be debilitating both physically and emotionally, and many treatments can be very costly and have uncomfortable side effects. With phototherapy, payers have a low cost alternative, providers a simple and effective solution, and patients a safe and easy natural alternative in the office or in the comfort of their own home.
We are committed to ensuring the highest standards of quality and compliance in our products and processes. Our Quality Engineering Manager will play a vital role in assisting with the development, validation, and improvement of manufacturing processes and systems. This role supports validation activities, ensures compliance with industry standards, and collaborates across departments to drive continuous improvement.
The Quality Engineering Manager will assist in managing quality systems, training teams on validation protocols, and maintaining compliance with regulatory requirements. The ideal candidate will have a minimum of 3 years of experience in quality engineering, validation, or a related field.
Essential Duties and Responsibilities:
Validation & Compliance:
- Assist with developing and executing validation master plans, test cases, and standard operating procedures (SOPs).
- Support validation and qualification of new or existing processes, equipment, and software in compliance with regulatory requirements.
- Prepare, maintain, and review validation documentation, including engineering change notices, schematics, and protocols.
- Assist in conducting audits to ensure adherence to internal quality standards and external regulatory requirements.
- Work with regulatory agencies to support compliance documentation and validation results.
- Assist with validating or characterizing sustainable or environmentally friendly products using electronic testing platforms.
Process Improvement & Testing:
- Assist with analyzing validation test data to determine if processes meet validation criteria and identify potential production issues.
- Support troubleshooting and root cause analysis for process deviations and recommend corrective actions.
- Assist in developing and optimizing sustainable or environmentally friendly validation methods.
- Monitor validation test equipment and ensure proper maintenance.
- Work cross-functionally with engineering, production, and regulatory teams to ensure quality objectives are met.
- Assist in training operators and staff on validation protocols, testing methods, and quality compliance.
- Participate in internal and external training programs to stay up to date on validation principles and industry trends.
Regulatory Compliance & Risk Management:
- Assist in communicating with regulatory agencies regarding compliance documentation and validation results.
- Support the preparation and maintenance of validation documentation, such as engineering change notices, schematics, or protocols.
- Collaborate with the Regulatory Affairs team to ensure products meet domestic and international regulatory requirements.
- Support the identification, assessment, and mitigation of quality-related risks throughout the product lifecycle.
Product & Process Quality:
- Assist in designing validation study features, such as sampling, testing, or analytical methodologies.
- Assist with evaluating product non-conformances and supporting corrective and preventive actions (CAPAs).
- Support the management of product and manufacturing process validations and verifications, ensuring proper documentation and compliance.
Validation Testing & Reporting:
- Help coordinate the implementation of validation testing with affected departments and personnel.
- Support the preparation of validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment.
- Assist in preparing detailed reports or design statements based on results from validation and qualification tests.
Supervisory Responsibilities:
This position assists in managing quality engineering activities but does not have direct supervisory responsibilities. The role involves supporting, mentoring, and training team members rather than directly overseeing them.
Qualifications:
To perform the job successfully, the individual should demonstrate the following competencies to perform the essential functions of this position:
- Knowledge of validation principles, regulatory compliance, and industry standards (e.g., FDA, ISO 13485).
- Experience with process validation, equipment qualification, and software validation.
- Proficiency in data analysis, root cause investigations, and statistical tools for quality improvement.
- Familiarity with automated testing platforms, electronic tracking systems, and database management.
- Ability to collaborate effectively across teams and assist in training initiatives.
- Analytical thinker with strong problem-solving and effective time-management skills.
- High attention to detail and organizational skills.
Desired Education and/or Experience:
- Bachelor's degree in Engineering, Quality Assurance, or a related discipline (or equivalent experience).
- Minimum of 3 years of experience in quality engineering, validation, or a related field.
- Experience with validation testing in regulated industries such as pharmaceuticals, medical devices, or electronics is preferred.
- An equivalent combination of education and experience.
Language Skills:
- Excellent verbal and written communication skills
Physical Demands:
- Ability to lift up to 50 pounds.
- Ability to stand, walk, and move throughout various environments.
- Office and manufacturing/laboratory environments.
- May require occasional on-site visits for validation testing.
Travel Requirements:
Travel may be required (up to 10%) for validation activities, regulatory audits, equipment qualifications, and training sessions in accordance with industry and company requirements.
Seniority level
- Seniority levelMid-Senior level
Employment type
Job function
- Job functionQuality Assurance, Engineering, and Management
- IndustriesManufacturing
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