Top 37967 Staff Quality Engineer Jobs

Staff Quality Engineer
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- Full-time
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- Bachelor of Science
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Staff Quality Engineer

Nuclein -
Austin, TX

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Job Details

Full-time
11 days ago

Qualifications

Regulatory inspections
Communication with suppliers
Quality records maintenance
Management
Quality control product testing
Calibration
Supplier corrective action implementation
New product development
ISO standards
Bachelor of Science
Document control experience within manufacturing industry
Production deviation management
Quality control preventive actions
Corrective and preventive actions (CAPA)
Quality improvement leadership
Vendor compliance audits
Manufacturing standard operating procedures
Supplier audits
Collaboration with product development teams
Vendor compliance management
Bachelor's degree in engineering
Production validation processes
Quality risk management
Medical device manufacturing facility experience
Quality assurance standard operating procedures
Compliance documentation
Supplier development
Mentoring
Leading team collaboration initiatives
Regulatory/legal compliance standards in production

Full Job Description

Position Summary.

The Staff Quality Engineer will support the development, and maintain key elements, of the Nuclein quality management system. Reporting to the Associate Director, Product Quality, this role will provide quality oversight of activities surrounding production, design and compliance. In collaboration with Operations, Engineering, and Assay Development colleagues and Nuclein’s suppliers, the Staff Quality Engineer ensures that our products meet the highest standards of quality and are compliant with all applicable regulations. This role handles escalated issues independently and proposes practical solutions to resolve challenges and make improvements. Serves as Subject Matter Expert in at least one quality discipline, such as Risk Management, Process Validation, Design Control, etc. This role is intended to be multi-disciplinary supporting production, design and regulatory efforts as needed.

Essential Duties and Responsibilities.

Ensures manufacturing and testing of medical device IVDs is performed in accordance with Nuclein procedures and Good Manufacturing Practices (GMPs)

Completes documentation to the standard for external Regulatory Body review

Reviews and approves manufacturing and testing/inspection records, and authorizes product release

Leads the generation/approval of documents related to equipment qualification, facility qualification, process validation, test method validation, and risk management (PFMEA, hazard analysis, etc.)

Generates/reviews/approves equipment specifications, calibration/preventive maintenance reports, Nonconformances, Deviations and other quality records

Leads cross functional teams on complex projects achieving timelines and mentors others on the principles of quality

Quality representative for complex on-market design changes, new product development and regulatory submissions

Facilitates the Nuclein supplier quality management program and guides cross-functional partners through supplier selection, change control, and qualification processes

o Conducts supplier audits (up to 10% travel)

o Manages supplier change requests, notifications, deviations, and corrective action requests

Reviews/approves in complaints and related investigative activities

Leads the development and improvement of the QMS through the creation of processes and authoring of procedures

· Hosts internal and external inspections/audits

· Manages external resources responsibly

Performs other duties and responsibilities as assigned by management

Education, Qualifications, and/or Experience.

B.S in Engineering or Science related field or equivalent experience required.

10+ years experience in a quality field required, experience in medical device ISO 13485 environment, or similar FDA regulated industry required

Experience working with IVDs preferred (PCR technology/platform a plus)

Expert experience in at least one quality discipline

Experience interfacing directly with external resources (suppliers, regulatory bodies, consultants)

Demonstrated ability to lead cross functional teams to achieve timelines

Have excellent written and verbal communication skills, with ability to train others in quality principles and operations

Physical Requirements.

· Repetitive Motion: Mostly computer use

Weight Lifting: < 25 lbs

· Position: Mostly sitting

Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

CANDIDATES MUST CURRENTLY LIVE IN THE AUSTIN, TX AREA - NO SPONSORSHIP IS OFFERED AT THIS TIME

Apply Now

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