Omnicell

Supplier Quality Engineer II

Omnicell • $85K — $95K *
Pittsburgh, PA 15237In-Person
Manufacturing & Automotive
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Minimum 3 years of quality/manufacturing experience in a relevant field.
  • Bachelor's degree in Engineering or Technical Science.
  • Proven knowledge of ISO 9001 or ISO 13485 auditing methodologies.
  • Familiarity with quality tools such as Pareto, fishbone diagram, and FMEA.
  • Strong communication and presentation skills across organizational levels.
  • Ability to effectively manage time and multiple detailed projects.

Responsibilities

  • Collect and analyze supplier performance data from ERP and PLM systems.
  • Create metric reports and presentations for internal and supplier reviews.
  • Lead supplier corrective action requests addressing product quality issues.
  • Plan and execute supplier audits to ensure compliance with quality standards.
  • Develop and implement strategies for enhancing supplier performance.
  • Support New Product Introduction teams with component qualifications at suppliers.
  • Review and approve supplier protocols and validate sampling sizes.

Benefits

  • Hybrid work environment based in Warrendale, PA.
  • Opportunity for international travel (up to 30%).
  • Engagement in corporate quality improvement projects.
  • Commitment to continual improvement of processes.
Full Job Description
Job Description

Supplier Quality Engineer (SQ Engineer II) - 5322

Reporting to the Senior Manager of Global Supplier Quality, this individual will be based out of an Omnicell US Manufacturing Facility. This role's primary function is to ensure quality standards are implemented and effective throughout Omnicell's Manufacturing and Service Supplier's. This SQE department member will also closely work with Global Supply Chain, Development and Manufacturing Engineering personnel at Omnicell to understand current product quality issues and assist with root cause and corrective action with suppliers.

Responsibilities:
  • Data collection, analysis, and trending of supplier performance data from ERP system and PLM database.
  • Creation of metric reports and presentations for Internal, Supplier QBRs and Management Review.
  • Lead SCAR activities for supplier product and process quality issues, ensuring all facets of CAPA activities are addressed including effectiveness.
  • Work with existing and new suppliers by planning and executing audits to ensure performance to Omnicell quality standards and regulatory requirements are be met.
  • Ability to develop, communicate & implement strategies for improving performance of Omnicell's Manufacturing & Service suppliers.
  • Partner with New Product Introduction teams to support successful component qualifications at suppliers.
  • Work closely with other QA departments within the Omnicell Global Factory Network on assigning and monitoring effectiveness of Supplier Corrective Actions in a timely manner.
  • Provides supplier quality support of Omnicell's suppliers engaged in the production of components.
  • Review and approve Supplier IQ/OQ/PQ Protocols and Final Reports, verifying that sampling sizes are statistically valid.
  • Work with suppliers to establish and maintain controlled manufacturing processes utilizing Control Plans and PFMEA's and PPAPS.


Additional Responsibilities:
  • Act as a change agent who accepts and supports new ideas and processes.
  • Commitment to cost reduction/controls.
  • Support the ongoing maintenance and continual improvement of Supplier Quality processes.
  • Update/creation of internal procedures as required.
  • Participate in corporate quality improvement projects as required.


Required Knowledge and Skills:
  • Proven working knowledge of auditing methodologies associated with ISO 9001 or ISO 13485 standards.
  • Quality concepts/tools (Pareto, fishbone diagram, FMEA, PPAP, etc.).
  • Proficient understanding of engineering and manufacturing terminology and processes.
  • Excellent comprehension of engineering drawings and specifications.
  • Proactive, self-motivated, and empathetic work ethic in a fast-paced work environment.
  • Ability to effectively interface and communicate with multiple constituents, including senior management, suppliers, consultants, and employees of all levels.
  • Ability to work collaboratively with peers and team members.
  • Strongly demonstrated written and verbal communication and presentation skills to all levels of an organization.
  • Refined multi-tasking and time management skills.
  • Ability to consistently balance sense of urgency with diplomacy/empathy.
  • Ability to make decisions and execute directives.
  • Strongly demonstrated attention to detail.
  • Strongly demonstrated organizational and project management skills.
  • Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project).
  • Ability to work under tight deadlines and handle multiple detail-oriented projects.
  • Self-starter, organized, analytical and decisive.


Basic Qualifications:
  • Minimum (3) years quality/manufacturing experience
  • BS Degree in Engineering or Technical Science

PREFERRED QUALIFICATIONS
  • ISO 13485 or FDA regulated medical device experience
  • ISO 9001, ISO 14001, 21CFR820 experience
  • Certified Lead Auditor


WORK CONDITIONS
  • Hybrid environment working out of our Warrendale, PA location (15086)
  • May travel up to 30% (Including international)


COMPENSATION
  • 85,000-95,000K


About Omnicell

Omnicell, Inc. is an American multinational healthcare technology company headquartered in Mountain View, California. It manufactures automated systems for medication management in hospitals and other healthcare settings, and medication adherence packaging and patient engagement software used by retail pharmacies. Its products are sold under the brand names Omnicell and EnlivenHealth.
Learn more about Omnicell
Size
3,800 employees
Market Cap
$2 billion
Industry
Technical Services
Net Income
$32.1 million
Founded
1992
5 Year Trend
+10.2%
Revenue
$892.2 million
NASDAQ
OMCL
* Ladders Estimates

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