Product Quality Assurance Specialist
hace 2 semanas
We are seeking a highly skilled Product Quality Assurance Specialist to join our team at Quality Consulting Group, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry.
About the RoleThis is an exciting opportunity for a motivated individual to work with a world-class manufacturing industry in Puerto Rico & USA. As a Product Quality Assurance Specialist, you will be responsible for formulating, delivering, and managing projects assigned by stakeholders to achieve desired results.
The majority of your time will be spent delivering R&D, systems, or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.
You will develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished materials products.
Your collaboration with engineering and manufacturing functions will ensure quality standards are in place.
You will devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
You will design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
You will ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Requirements- Bachelor's degree in engineering (Software, Mech, and Chem Engineering preferred)
- 4 years of relevant experience
- Experience reviewing and approving validation test plans, reports, and deviations
- Capable of performing statistical analysis to support validations and product release
- Knowledgeable of medical devices manufacturing regulations
- Ability to use statistical techniques to analyze data
- Collaborative attitude
- Experience in CSV
- Experience in medical device industry
- Experience in Process Validation and Equipment qualification
- Experience in risk management documents (e.g., pFMEA)
- Experience in manufacturing events investigations
The estimated salary for this role is $60,000 - $80,000 per year, depending on qualifications and experience.
BenefitsQuality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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