Quality Engineer

Compunnel Inc.; Cedar Creek (NE); On-site; USD 49,593 - 55,104; Full time

Benefits offered by this job

Relocation assistance

Job summary

A leading technology firm is seeking a Quality Engineer to drive quality assurance in life sciences at their Cedar Creek location. The role includes leading audit preparations, supporting regulatory compliance, and tackling investigation projects. Ideal candidates hold a relevant degree and have at least 4 years of experience in the industry. Strong analytical and communication skills are essential. The position offers competitive pay in a contract role.

Qualifications

• 4+ years of experience in a similar position within the Life science industry.
• Familiarity with medical device regulations (ISO 13485, FDA 21 CFR part 820).
• Post-graduate quality assurance certifications preferred.

Responsibilities

• Drive quality assurance activities related to batch review.
• Support 3rd party audits and participate in audit prep.
• Lead root cause investigations for various issues.

Skills

Quality Assurance

Analytical Skills

Communication

Teamwork

Education

Bachelor’s or Master’s Degree in biology, chemistry, biotechnology, or engineering

Job description

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This range is provided by Compunnel Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$36.00/hr - $40.00/hr

Direct message the job poster from Compunnel Inc.

Quality Engineer – Advanced

Location: Cedar Creek, Texas

Duration: 12-18 months

Shift – 1st start time is usually anytime between 8am-9am and plan on working 8 hours days

Additional responsibilities will include:

· · Drives quality assurance activities related to batch review, change control, NCRs, Deviations, CAPAs, Audits, and supports Product Complaints technical investigations for the relevant product platforms.

· · Support 3rd party audit of site through audit prep and participating in the front/back room.

· · Apply advanced Quality Assurance and Scientific Method techniques and principles to daily tasks and activities.

· · Apply relevant regulations, standards, GxP requirements, and industry best practices to assignments.

· · Plan and conduct projects and activities with moderate to high technical responsibility, complexity, and strategic feedback.

· · Act as an SME in quality assurance and scientific matters as applicable.

· · Develop and drive key strategic quality assurance initiatives throughout the organization.

· · Contributes to the development of new projects/programs/processes.

· · Lead/drive root cause investigations for multiple issues, including complaints, NCRs, Deviations, OOS, etc.

· · Leads projects requiring representation of the organization to internal and/or external customers or others, providing expertise and promoting solutions.

Job Posting Qualifications

· · Bachelor’s or Master’s Degree in biology, chemistry, biotechnology, engineering, or a related field required

· · Post-graduate, Quality Assurance Certifications, such as Six Sigma, CQE, CQA, etc., is preferred.

· · 4+ years of experience in a similar position within the Life science industry required

· · Familiarity with medical device regulations, such as ISO 13485, FDA 21 CFR part 820, and IVDR 2017/746 is required.

· · Strong organizational and analytical skills with a focus on finding effective and efficient solutions in compliance with the regulations.

· · An effective communicator at all levels, both internally and externally.

· · Team player with the ability to make independent decisions within the framework and guidelines of the organization.

· · Relocation assistance is available.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Medical Practices and Medical Equipment Manufacturing

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