Senior Quality Assurance Engineer
3 days ago
**Job Title:** Senior Quality Assurance Engineer
**Job Summary:** We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Planet Pharma. As a Senior Quality Assurance Engineer, you will be responsible for ensuring the quality of our products and processes, and for developing and implementing quality assurance programs.
Key Responsibilities:
- Develop and implement quality assurance programs to ensure compliance with regulatory requirements and company policies.
- Conduct risk assessments and develop risk mitigation strategies to minimize the risk of product failure.
- Develop and maintain quality standards and protocols for processing materials into partially finished or finished products.
- Implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Specify inspection and testing mechanisms and equipment, conduct quality assurance tests, and perform statistical analysis to ensure products meet required standards and specifications.
- Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- Perform detailed root cause investigations of failed products or processes using various quality tools.
- Interface with production, manufacturing, process engineering, R&D, and regulatory departments to resolve process issues and implement changes.
- Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of products through the production line.
- Identify, analyze, and manage risk through the product life cycle using risk management tools.
Requirements:
- Advanced knowledge of quality assurance principles and practices.
- Minimum of 4 years of experience in quality assurance or a related field.
- University degree in a relevant field, such as engineering, science, or quality assurance.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Ability to prioritize tasks and manage multiple projects simultaneously.
Preferred Qualifications:
- ASQ Quality Engineer Certification.
- Bilingual English/Spanish preferred but not required.
- Previous medical device experience is helpful.
- DMAIC Lean / Six Sigma Certification.
- Manufacturing experience within a controlled and regulated industry.
What We Offer:
- A competitive salary and benefits package.
- Opportunities for professional growth and development.
- A dynamic and collaborative work environment.
- The chance to work on challenging projects and make a meaningful contribution to the company's success.
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