Sr Quality Engineer Jobs

D & K Engineering (a Burke Porter Group Company) in Rancho Bernardo is looking for a Sr Quality Engineer.

The Sr Quality Engineer works closely with Program Managers, Engineering, Supply Chain, Manufacturing Operations, and other Quality resources to assure effective application of the D&K Quality System to multiple contract design and manufacturing programs. The QE is responsible for developing the Quality Plan in line with client requirements, company policies, ISO standards, and regulatory requirements (where applicable). This plan defines the level of quality system engagement, control, and documentation commensurate with project scope, product function, and risk.

The Quality Engineer also works collaboratively with cross-functional teams to identify and implement best practice processes, tools, and training for organizational learning and growth.

ESSENTIAL FUNCTIONS:

As required for each program, the QE will perform the following duties:

• Review and approve program non-conformances (NC) & material review board (MRB) dispositions.
• Work with Engineering and Supply Chain to define part quality plans at a component level
• Lead or participate in internal/external Quality System audits.
• Work with Program Managers/Project Teams to evaluate design/system requirements, support trace matrix development and updates, and establish appropriate test plans
• Perform other duties as assigned
• Work with Supplier Quality, Procurement, and/or external suppliers to review, approve, monitor, and update Supplier Control Plans, Tool Transfer Plans, and Part Qualification Plans for assigned programs.
• Ensure process improvement activities remain in compliance with FDA/ ISO regulations/ standards/ guidelines and customer requirements.
• Help establish Program Manufacturing Quality Metrics
• Report Program Manufacturing Quality Metrics to stakeholders
• Oversee manufacturing process qualification activities and ensure compliance with relevant standards and procedures; create and/or review Manufacturing Qualification Plans and Reports as required.
• Lead problem-solving efforts, including customer complaint investigation and analysis to identify and resolve sporadic and chronic quality issues to ensure production of safe and effective products.
• Review changes to products in production for reliability impact to aid in the correction process, design or material problems.
• Assure compliance with hardware and software development SOPs applied at a project level
• Represent Quality in planning, design, NPI, and production process development on product development teams
• Review Made-to-Print specifications with Engineering and D&K Inspection, provides guidance to D&K Inspection a Program’s Part Quality Plans
• Provide scope of work & direction to the Program Quality Analyst
• Coordinate risk management activities

EDUCATION, EXPERIENCE, SKILLS AND ABILITIES REQUIRED:

Education:

Bachelor’s degree in Engineering or equivalent science discipline, preferably Bioengineering, Mechanical, Electrical, Software, Industrial, or Quality Engineering.

Experience:

Typically requires 8+ years related experience with a Bachelor’s degree, or 5-8 years related experience with a Master’s degree. Must have design and production support experience in a regulated environment.

Job Complexity:

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.

Knowledge, Skills & Abilities:

Proficient in ISO Standards (ISO 9001, ISO 13485 required, & ISO 14971 preferred)

Working knowledge of FDA Quality System Regulations (21 CFR Part 820) highly preferred

Knowledgeable in Safety standards and Compliance

ASQ certifications such as CQE preferred

SUPERVISION: Normally receives little instruction on day-to-day work, general instructions on new assignments.

TECHNICAL KNOWLEDGE:

Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines or ability to be trained.

Software Knowledge: Windows, MS Office (Word, Excel, Access, PowerPoint)

EFFORT REQUIRED:

Physical Activities: On a continuous basis, sit at desk for a long period of time; write or use a keyboard to communicate through written means. Intermittently answer telephone. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

TRAVEL:

This position may require occasional travel

Relocation will be considered.
From: D&K Engineering