Senior Engineer, Quality - Sustaining & Validation

ICU Medical; Salt Lake City (UT); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device company is seeking a Senior Quality Engineer to provide technical quality engineering support in Salt Lake City. The role involves enhancing quality performance and ensuring compliance with industry regulations. Candidates should have a Bachelor's degree in engineering, over 7 years of experience, and a strong knowledge of FDA regulations. The position offers opportunities for continuous improvement and project management, along with a collaborative team environment.

Qualifications

• 7+ years of experience in quality engineering or related fields.
• Strong knowledge of FDA regulatory requirements.
• Experience in technical writing of documents in regulated industries.

Responsibilities

• Provide technical quality engineering support for quality assurance.
• Implement quality engineering tools for process improvements.
• Develop and execute validation protocols for manufacturing equipment.

Skills

Quality toolbox including six sigma methodology

Lean principles

Advanced statistics

Excellent communication skills

Organizational skills

Creative problem solver

Education

Bachelor’s degree in relevant engineering field

CQE Certification

Tools

Microsoft Office (Excel, Word)

Statistical analysis programs (Minitab)

Job description

Job Description

The Senior Quality Engineer – Sustaining and Validation (Quality Operation) provides hands‑on technical quality engineering support and direction in quality assurance and quality control aspects of the SLC operation to facilitate an environment of compliance and meeting business objectives. The role involves completing advanced validation projects, leading initiatives to enhance quality performance, and ensuring compliance with applicable regulations and standards.

Essential Duties & Responsibilities

• Partner with Engineering, Maintenance, Production, Quality Operation and other functions to drive prompt resolution of quality problems for product and processes and to drive the highest quality results.
• Implement quality engineering tools in the operation to drive methodical and process‑based approaches to product and process improvements.
• Develop and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, processes, and software systems.
• Develop and execute Test Method Validations for manufacturing processes and laboratory equipment, as needed.
• Develop/update sampling plans by applying attribute, variable, and sequential sampling methods.
• Develop/update local procedures, Test Methods, and standards.
• Manage/develop validation studies on equipment, automation software & processes.
• Process and investigate quality issues methodically in a high‑paced, efficient and accurate manner.
• Escalate significant quality issues observed while running the processes under responsibility and propose solutions.
• Lead continuous improvement activities for the validation program and revise, create and approve validation documents and procedures.
• Analyze, plan, organize and complete complex projects; develop scope and provide creative solutions.
• Produce and optimize inspection methods and sampling.
• Improve the Quality System through internal audits and compliance audits.
• Deliver communications tailored to managers, peers and project stakeholders; resolve conflicts collaboratively.
• Coach and mentor others in quality topics and activities; may provide input on performance evaluations.
• Work effectively in a team environment with shifting priorities and time‑sensitive requirements.
• Perform other functions as necessary or as assigned.
• Work on special projects as they arise.

Knowledge, Skills & Qualifications

• Ability to train/transfer knowledge to others.
  • Proficiency in quality toolbox including six sigma methodology, lean principles, advanced statistics and other proven quality tools.
  • Has an advanced understanding of validation and regulatory requirements.
  • Use of measurement and test equipment.
  • Creative problem solver with the ability to troubleshoot a variety of issues.
• Proficient in Microsoft Office (Excel, Word, Database) and statistical analysis programs (Minitab highly preferred).
  • Excellent written and verbal communications skills.
  • Strong organizational skills and high level of attention to detail.
  • Knowledge of plastic processing, automated and manual assembly of disposable Medical Devices.
  • Knowledge of basic Geometric Dimensioning & Tolerancing (GD&T) concepts.
  • Good mechanical aptitude.
  • Experience managing personnel (desirable).

Education & Experience

• Must be 18 years of age.
• Bachelor’s degree in Chemical, Biomedical, Mechanical, Industrial, or Manufacturing Engineering (or related STEM field).
• CQE Certification desirable.
• Experience working in a team environment successfully bringing medical device products through an FDA regulatory pathway and compliance with internal Quality Management System (QMS).
• Experience in technical writing of documents in regulated industries.
• Strong knowledge of medical device validation processes, risk management, and regulatory requirements (FDA 21 CFR Part 820, ISO 14971, ISO 13485).
• 7+ years’ experience.

Physical Requirements & Work Environment

• This is largely a sedentary role.
• The employee is occasionally required to work inside a clean room/controlled area environment.
• The job operates in a professional office environment and routinely uses standard office equipment; may perform duties in a laboratory environment.
• Must be able to occasionally move objects up to 25 lbs.
• Typically requires travel less than 5% of the time.

About ICU Medical

ICU Medical has consistently provided clinical innovations that solve real‑world challenges. With acquisitions of Hospira Infusion Systems and Smiths Medical, we are a global market leader with a complete line of clinically‑essential IV therapy and high‑value critical care products. We bring consistent quality, innovation, and value in more areas than ever.

EEO Statement

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [e-mail]. We are committed to providing equal access and opportunities for all candidates.