Senior Engineer, Quality - Sustaining & Validation
Position Summary
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.
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.
Have the ability to methodically process and investigate in a high-paced, efficient and accurate manner.
Proactively 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 projects of a very complex nature.
Develop scope and provide creative solutions.
Plan, organize and conduct technical projects.
Be proficient in and make continuous strides towards optimization of inspection methods and sampling.
Improve Quality System through internal audits and compliance audits.
Deliver communications tailored to the needs of the receiver (managers, peers, project stakeholders) with appropriate frequency to promote cross-functional collaboration.
Bring substantive conflicts and disagreements into the open and attempt to resolve them collaboratively; build consensus.
Coach and mentor others in quality topics and activities.
May provide input on performance evaluations to area manager.
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.
Advanced understanding of validation and regulatory requirements.
Use of measurement and test equipment.
Creative problem-solving ability 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 And Experience
Must be 18 years of age.
Bachelor of Chemical, Biomedical, Mechanical, Industrial, or Manufacturing Engineering (or related field STEM).
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 And Work Environment
Largely a sedentary role.
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 Us
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
ICU Medical 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 or belief, 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 humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates. ICU Medical EEO Policy Statement Know Your Rights: Workplace Discrimination is Illegal Poster