Quality Engineer

Location: Irvine, CA
Department: Azzur of CA, LLC

Job Description

Do What You Love

At Azzur Group, it is our purpose to foster a culture that attracts and enables individuals with unique abilities and passions to reach both their life and career goals.  We take crucial steps to ensure that each employee is fulfilled both in and out of the office.

In addition to our purpose, we have a set of core values that we live and breathe each day. Every benefit offered here at Azzur is designed to uphold our 5 core values; Integrity, Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility and Having Fun. 

It is our mission to serve our communities, build positive and established relationships, create a healthy and fun work environment, ensure each employee and their families are healthy and thriving, grow each employee professionally with one of our customized training programs and keep a clear and open line of communication.

We are an equal opportunity employer and promote diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.

If philanthropy, long lasting relationships, a clear career path forward and a positive, transparent and fun company culture are something you are looking for in your next role, Azzur is the place for you.

 

Ideal Qualities:

Ideal candidates will exhibit, or have the willingness to develop, the following qualities:

  • Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
  • Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
  • Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others. 
  • Understands worldwide regulations and phase appropriate applications
  • Draws insights from projects and supplemental research to help drive new and existing growth. 
  • Ensures activities are efficient, optimized, and client-centric. 
  • Highly motivated and organized, solutions oriented leader
  • Curious and adaptable - has the ability to transform knowledge into actionable activities
  • Able to produce results in a fast paced, collaborative environment   

 

Essential Duties and Responsibilities

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project.  The level of knowledge expected will be commensurate with level of incoming experience.

 

  • Provide technical support and compliance solutions to Quality Assurance/Control organizations
  • Review and approve validation using IQ/OQ/PQ methods and reports
  • Conduct root cause analysis and investigations, perform technical assessments, and complete validation and qualification studies by managing GR&R’s and FAI’s, Control Plans and Capability Studies
  • Provide technical support using a risk-based approach to resolve quality related issues in throughout the Quality Systems lifecycle
  • Design and conduct Quality Engineering studies to define causes of quality non-conformances
  • Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)

 

Qualifications

 

  • BS in Engineering, Science or equivalent technical degree
  • 3-5+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry
  • Experienced leader in Quality Management Systems (QMS) for pharmaceutical, biologics, combination, and medical device products. Experience with establishing and sustaining best practices to meet industry standards
  • Knowledge and experience in pharmaceutical and medical devices in conformance with ICH guidelines, 21CFR Part 11, Part 210 & 211, Part 820 Quality System Regulation
  • Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.)
  • Excellent written and verbal communication skills; excellent technical writing skills
  • Strong interpersonal skills and the ability to work in a team environment
  • Ability to work effectively in a fast-paced multitasking environment
  • Strong working knowledge of FDA and cGMP regulations and documentation practices
  • Proficient in Microsoft Word, Excel, PowerPoint
  • Working for multiple clients throughout the region

 

 

Perks of Working at Azzur West

 

  • Medical, Dental and Vision
  • Competitive 401K plan
  • Volunteer Paid Time Off
  • Flexible Paid Vacation Time
  • Employee Recognition Program
  • Diversity and Inclusion Initiatives
  • Training and Mentorship Opportunities

 

Find us on social media 

Instagram: Azzur_LA

View our culture video in Youtube: https://www.youtube.com/watch?v=GPNjmsDu0LY


Apply Now

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