Quality Engineer II

Posted 18 Days Ago
Be an Early Applicant
Juncos
Mid level
Biotech • Pharmaceutical
The Role
The Quality Engineer II develops and maintains quality standards and protocols for materials processing, collaborates with engineering and manufacturing to ensure standards are met, designs testing mechanisms, conducts quality tests, performs statistical analysis for product reliability, and ensures documentation compliance.
Summary Generated by Built In

JOIN OUR TEAM!

PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.
Location - Juncos, PR 
Requirements:

  1. Basic knowledge in quality manufacturing operations Nonconforming product, Yield, Pareto defect, Bounding.
  2. Basic knowledge in Statistical Process Control.
  3. Basic Process Validation knowledge in Process Validation.

Education Required: B.S in Engineering.

 Years’ Experience Required: 2-5 Years

JOB DESCRIPTIONResponsibilities may include the following and other duties may be assigned. 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. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. 


PharmaLex is an Equal Opportunity Employer.

Top Skills

Statistical Process Control
The Company
HQ: Burlington, MA
1,385 Employees
On-site Workplace
Year Founded: 1994

What We Do

PharmaLex is a leading provider of specialized services for the pharma, biotech and medtech industries.

We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval/maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results - going above and beyond the standard to deliver tailor-made solutions worldwide.

The PharmaLex Group now has over 3000 employees, with 68 offices in 32 countries and more than 1000 satisfied clients worldwide.

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