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Area Quality Lead

Description

Want to set the standard for quality? As Area Quality Lead you’ll have the freedom to ensure our manufacturing raises the bar even further. 
 
 Area Quality Lead 
 Salt Lake City, UT 
Competitive Salary & excellent benefits package 

Medical, Dental, Vision and Prescription insurance – eligible on your 31st day of employment
Bonus Programs
401(k) and Profit Sharing
4 Weeks’ Vacation annually
Parental / Maternity Leave
Tuition Reimbursement
Employee Assistance Program
On-Site Gym
On-Site Employee Store
And Much More!


Quality counts here. Working in a fast-paced production environment, you’ll ensure we meet the highest quality standards. Every time. You’ll:
•    Build relationships to improve current practices and prevent mistakes
•    Create training, technical manuals and audits
•    Work with colleagues and suppliers to ensure our brand reputation
•    Ensure our customers can continue to depend on us for product excellence. 

 

You’ll succeed because… 
…you’re committed to quality. You’ve a background in manufacturing as a team leader, a quality leader or a wealth of experience in healthcare manufacturing. You:
•    Work best autonomously, taking ownership and initiative for your own results
•    Understand quality controls, technical manuals and complaints processes
•    Are diplomatic, constructive and tactful which means you can influence people to change and improve working practices and processes
•    Collaborate effectively and can lead improvement. 

 

You’ll love it because… 
…you’ll get to make an impact like never before. You’ll be responsible for your own projects - we can’t wait to listen to your ideas. The products you get out there will make people’s lives better. Our iconic brands will provide an incredible platform for you. And our dynamic, ownership-driven culture will help bring the very best out of you, every day. 
 

Responsibilities

  • Owns all area specific deviations and non-conformances from the quality perspective partnering with the manufacturing team and all other necessary support roles. 
  • Interface with engineering support, Technical, Cl Team, suppliers and R&D.
  • Support Groups in delivering in-house & regulatory standards of compliance to best business advantage
  • Training and competency assessment of operational staff.
  • To advise on, and assist with, practical operation changes and improvements
  • Identifies and supports actions to resolve quality problems, both internal issue and from outside suppliers
  • Identifies with PSL where support is required from support teams.
  • Makes recommendations and acts to improve process, procedures and systems.
  • Assesses change controls, protocols and NCRs, recommends release or otherwise of product involved.
  • Co-ordinate area document control and assists with training regarding quality system
  • Chairs Quality Sections of Group meetings.
  • Resolving on-line issues regarding quality to the point of stopping production operation and
  • Ensuring quality requirements and production requirements are considered, without detriment to either
  • Product release or reject recommendation in the event of significant quality issues

Qualifications

  • Ability to lead the development and implementation of quality processes to assure regulatory compliance, leading cross-functional technical personnel, and coordinating the execution of multiple complex projects in a fast-paced environment.
  • Must have a strong working knowledge of applicable parts of Title 21 of the CFR, ICH & Competency of specific cGMPs, and thorough understanding to manufacturing operational processes in the Nutraceutical, pharmaceutical or medical device industry.
  • Experience using electronic quality management tools such as MasterControl or TrackWise is a PLUS.
  • Must have experience with quality tools such as: SPC, Advanced Quality Planning, Control Plans, FMEA, Root-Cause Analysis, Six Sigma, cross-functional problem-solving teams, etc.
  • Experience with agents of governmental regulatory bodies as well as internal and external customers and suppliers; participation and support of regulatory audits.
  • Must exhibit excellent communication and facilitation skills, both oral and written. Able to debate and negotiate with personnel from all supply functions personnel and communicate to all levels of the business with confidence. Well-developed influencing skills.  Diplomatic and tactful in difficult situations
  • Associates degree in a scientific or technical field 
  • Candidate shall have 3-5 years of quality assurance work experience in a Nutraceutical/Pharmaceutical/Medical device industry or equivalent.

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law. 


Nearest Major Market: Salt Lake City

Job Segment: Medical, Medical Device, Healthcare

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