Quality Engineer - Design at 6270 GenMark Diagnostics, Inc. in Carlsbad, California

Job Description:

The Position

Description Responsibilities: 

• Provide Design Control guidance to product development under direction from Life Cycle Teams (LCT). Act as the single point representative for all Quality Management System activities for Project Teams.


• Review and approve documentation consistent with design control regulations and guidance, Roche Diagnostic Divisional Standards and business area/unit specific processes and procedures. Documentation includes, but is not limited to, design control-related documents such as design development plans, risk management plans/reports, customer requirements, product requirements, technical performance verification protocols/reports, clinical study plans/reports, design transfer documents, labeling, and milestone documentation.


• Communicate critical product quality or compliance-related issues to Quality Management to ensure alignment with Quality policy and objectives. Participate in difficult discussions, challenge the status quo, and identify mutually beneficial compliant solutions with cross-functional colleagues at the Project Team level. Work closely and partner with DQA colleagues within and across sites to ensure consistent application of design control-related processes.


• Author Quality Reports. Advise and support Project Teams during the planning of milestones to complete required deliverables. Assist management in assessment of whether the project has met requirements to pass milestone.


• Provide feedback on new or revised SOP’s associated with design control activities/compliance. May be the key contributor/coordinator for Quality feedback on SOP revisions working closely with the respective SOP owner and DQA leadership.


• Support internal and external audits/inspections. May Proxy for QFL as requested for LCT. Activities may include nonconformance review and approval, and document change review and Confidential Proprietary Information Page 2 of Design Quality Engineer August 2022 approval within Trackwise. Activities may include equipment installation qualification review and approval.

Who You Are:

• Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology or related discipline. Master’s degree is preferred. Or, equivalent combination of education and work-related experience.


• A minimum of 5+ years of experience under established quality regulations, including intermediate knowledge of medical device or pharma processes; 8+ years of experience working under established quality regulations with knowledge of in-vitro diagnostic products including nucleic acid based products is preferred.


• Strong track record of successful participation on cross-functional teams.


• Working knowledge of QSR/cGMP, ISO and Design Controls.


• Experience with product design controls during development of nucleic acid-based assays for
  disease detection and diagnosis in a regulated environment, preferably in a company
  manufacturing diagnostics product for the clinical lab and/or doctor’s office market.


• Experience in planning, coordinating and documenting controlled studies, including protocol
  development.

*Relocation assistance is NOT available for this role*

The expected salary range for this position based on the primary location of California is $83,800-$155,600.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

Who we are

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare.  As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses.  GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.