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Are you a technical, hands-on kind of Quality Engineer? Did your career begin in Manufacturing or R&D and quickly progress? What if we told you that you could get an opportunity to advance your job working within a fast-moving, forward-thinking, and global Medical Device Technology Company? We are asking you to explore your potential, see what you can achieve with a highly energetic team environment.

You'll get the opportunity to support one of our product lines that generates the most significant amount of sales growth in our Arvada Plant. This opportunity is vital in the continuation of improvements to critical processes; you will work in a rapidly changing environment, ensuring the compliance of all manufacturing and engineering processes in conjunction with regulatory are on point for Class II and III medical devices. Over time you will become the go-to person for perfusion products within the Quality Engineering Department.

Imagine your year one at a glance: Develop and Implement process improvements by:

Identifying root cause of product non-conformities and suggesting product and process improvements.

Improving receiving and in-process inspection and acceptance activities and production processes.

Collaborating with Operations to define and implement systems that enhance efficiency, productivity, and quality.

Lead CAPA by:

Recognizing which complaints and trends warrant investigation via the CAPA process and initiate CAPA investigations as required.

Identifying and initiating product and labeling improvements based on complaint and trending data.

Conducting and overseeing investigations for in-process non-conformances, audit non-conformances, and post-market events to identify root cause and corrective actions in a timely and compliant manner.

Monitor the effectiveness of corrective and preventive actions.

Provide solutions to technological problems as part of the sustaining engineering teams by:

Ensuring the design change projects comply with design control regulations.

Leading and revising risk management activities.

Ensuring verification and validation activities are sufficient and complete.

Reviewing and providing input into process validation activities.

Establishing Quality criteria (risk assessment, acceptance criteria, sample size, parameter definition).

Knowledge, Skills and Abilities Required:

2-4 years of hands on experience

Successfully demonstrates an in-depth or breadth of engineering skill(s).

Must have proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning

Ability to work within a changing environment.

Ability to work with a wide variety of personnel on all levels and utilize constructive confrontation

ASQ Certified Quality Engineer or other ASQ Certifications is a plus.

Knowledge of regulatory requirements (e.g., FDA, ISO) as required for the position.

Ability to analyze and problem-solve.

Excellent communication (written and verbal) and presentation skills.

Must be able to work in a clean room environment and tolerate chemical odors.

Must be able to work in a lab environment and tolerate the smell and sight of blood.

Must be willing to take on related duties as required in support of company and departmental... For full info follow application link.

LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.

Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classifi ation.