Omnicell, Inc. Quality Assurance Engineer III in Mountain View, California

Quality Assurance Engineer III

Description

Quality Assurance Engineer III

Omnicell is seeking a Quality Assurance Engineer III who will report to the Senior Manager Quality Engineering and be located at the Mountain View facilities located in California. The Quality Assurance Engineer III will be responsible for Design Assurance activities in collaboration with cross-functional personnel for design qualifications, risk management, process controls, verification and validations, & design transfer.

Responsibilities:

  • Participate in core team meetings and design reviews during all phases of the Product Development Process to serve as primary representative of Quality Engineering to the product development teams.

  • Contribute to the design and process Failure Mode Effects Analysis and System Hazard Analysis activities, design control, labeling control, change management, complaint handling, CAPA, and recall/field action.

  • Evaluate effectiveness of regulatory compliance processes and identify areas for improvement.

  • Review and approval of design verification and validation plans to ensure that design outputs meet the design inputs. Be responsible for creation and maintenance of design history file documents. Review and approval of design verification and validation summary reports ensuring that all defects, deviations and/or observations are sufficiently addressed or closed.

  • Assist in the establishment of quality acceptance criteria and activities including but not limited to incoming, in-process and final inspection.

  • Review pre-production verification process at a component level.

  • Support sustaining quality engineering activities to ensure released products meeting all applicable requirements.

  • Ensure production equivalency is reviewed, documented and tracked as required per verification and validation protocols.

  • Support change control process through the creation of documentation, ensuring adequacy of verification or validation to support the change, good documentation practices and compliance with procedures.

  • Ensure compliance to internal QMS documentation and ISO 13485:2016.

  • Establish quality metrics for design control conformance to demonstrate the level of effectiveness of the process.

Additional Responsibilities:

  • Support the Quality Department objectives and goals by managing or participating in Quality projects.

  • Manage and/or participate in CAPAs as required.

  • Act as a liaison between Quality and other Omnicell functional departments.

  • Lead or participate in Quality Management Review meetings.

Required Knowledge and Skills:

  • Ability to effectively interface and communicate with multiple constituents, including senior management, customers, consultants, vendors, and employees of all level.

  • Excellently demonstrated interpersonal, verbal and written communication skills, attention to detail, strong organization skills, and ability to work independently and in teams.

  • Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project).

  • Ability to work under tight deadlines and handle multiple detail-oriented projects.

  • Ability to deliver quality outputs under minimal supervision.

Basic Qualifications:

  • Bachelor's Degree in Engineering or Science discipline.

  • 5 years of Quality Engineering experience.

  • Minimum of three years of experience in a design assurance role supporting medical devices.

  • Working knowledge of FDA Quality System Requirements, ISO 13485, ISO 14971, and IEC 62304.

  • Track record of creating design history file documents.

  • Experience working with complex electro-mechanical systems.

  • Experience with broad variety of measurement and quality data analytic techniques.

Preferred Qualifications:

  • Expertise in ISO 9001:2015 and Medical Device Regulations such as FDA QSR and related standards (ISO 13485, ISO 14971, IEC-61010-2-101).

  • Technical Knowledge of global product regulations, including RoHS, REACH, WEEE, Safety, EMC, and other similar EU Directives.

  • PCBA and box-build experience.

Work Conditions:

  • Office Environment.

  • Travel up to 10% domestic and international.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

Omnicell will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.