QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
- Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
- The majority of time is 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.
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Qualifications:
- 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
- Available for 1st, 2nd or 3rd shift
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools.
Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
