Position Summary
JOB DESCRIPTION
The Supplier Quality Engineer is responsible for monitoring supplier quality performance, trending of supplier quality issues and initiating and approval of Supplier Corrective Action Requests (SCARs) in response to the related issues. This function will assess the suppliers’ capability of meeting the ICU Medical’s manufacturing standards along with the various regulatory standards, including FDA, Health Canada, EU, cGMP, ISO, and PIC/S. Additional responsibilities include maintaining the Approved Supplier Listing (ASL), assessment of Supplier Change Notifications, and owning/routing change controls, as needed. In addition, when the Supplier is a Third-Party Manufacturer (TPM), the Supplier Quality Engineer will review and approve TPM investigations.
Essential Duties & Responsibilities
- Assist as a liaison with the supplier and site management to resolve supplier quality issues, identify trends, and assure compliance with regulatory requirements.
- Assist in providing support for elevated issues such as recalls, field alerts, non-marketed and marketed complaints, and product investigations involving commodities.
- Maintenance of the ASL for use by the Austin site, including the addition of new suppliers, changes to supplier status, and performance of Risk Classifications and Mitigations as needed.
- Compile and assess Annual Product Quality Review (APQR) data, Monthly Management Review Metrics, and Supplier Monthly Scorecards.
- Assist with the auditing of suppliers against global and regulatory requirements and on-time generation and delivery of audit reports to meet metric requirements.
- Represent Austin Supplier Quality and be an active member of project and continuous improvement efforts.
- Update SOPs as needed to remain in compliance.
- Review change controls received from TPMs impacting ICU products. As required, coordinate with Austin site SMEs to assess the impact of the changes.
- Initiate Notification to Management and Field Alert Reports in response to deviations or Quality Notifications from TPMs and other ICU support organizations, as needed.
- Participate in meetings with TPMs and other ICU support organizations to discuss any open investigations, Out of Specifications, Change Controls, etc.
- Assist with the review and approval of impact risk assessments and track associated corrective and preventative actions (CAPA's) to assure timely closure.
- Perform other related duties as assigned or required.
Knowledge, Skills & Qualifications
- Pharmaceuticals, Medical Device or Regulated Industry knowledge and experience preferred.
- Strong organizational and problem-solving skills.
- Strong written and verbal communication skills and professionalism.
- Ability to work and adapt in a fast-paced environment.
- Proven experience with various computer software applications to track and trend quality metrics.
- Strong interpersonal skills with ability to interface with multiple levels of people in the organization, including plant personnel and outside service providers.
- Excellent facilitation/presentation skills and ability to facilitate strategy meetings.
Education And Experience
- Bachelor’s degree in chemistry, biology, microbiology, engineering or related field (STEM) from an accredited college or university is required.
- 1-3 years’ experience in Quality Assurance, Manufacturing, Engineering, or R&D functions or any combination.
- Prior experience in coordination with different teams and outside vendors, preferably in pharmaceutical industry.
- ASQ Certification(s) or other recognized certification program preferred but not required, Auditing certification preferred but not required.
Physical Requirements And Work Environment
- Typically requires travel less than 5% of the time.
- Office environment.
- Must be able to lift up to 20 lbs. unassisted.
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.
We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You
- Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
- The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
- IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
- Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement:
ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and 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 identity, gender expression, gender reassignment, 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
OFCCP Equal Opportunity Posters
“Know Your Rights” Poster
Pay Transparency Nondiscrimination Provision
ICU Medical CCPA Notice to Job Applicants
