Senior Quality Engineer

Full-time Regular
San Diego, CA, US

Salary Range:
$129,029.00 To $150,000.00 Annually

Job summary

The Senior Quality Engineer is an onsite position and very hands-on with Quality System elements such as NCMR’s, CAPA’s, Batch (DHR) release, change orders, drawing review, quality inspection records, and product disposition. The Senior Quality Engineer is responsible for developing, maintaining and analyzing supplier quality systems and procedures to ensure compliance with FDA regulations, corporate directives, ISO 13485 standards and company strategies. This position is also responsible for Quality input, technical support, conducting investigations, and providing guidance for Manufacturing, Engineering, and Regulatory Affairs, especially as related to product and components from suppliers.

This position is responsible for performing investigations and inspections as necessary and identifying and implementing quality assurance testing models for analysis of raw materials, materials in process, and finished products. The Senior Quality Engineer assists in developing quality control policies and evaluates production challenges and determines improvement opportunities.

Essential job functions and duties

• Lead and conduct on-site supplier qualifying and monitoring audits representing Inovio in a professional manner to ensure compliance with company requirements and expectations, including appropriate regulations & standards (e.g., FDA’s 21 CFR 820, ISO 13485 & ISO 9001, etc.)
• Leads root cause analysis of defects to identify and drive corrective actions.
• Ownership of QMS elements such as CAPA’s, NCMR’s, Complaints etc.
• Develop, author, and implement quality assurance protocols for mechanical systems, components and product testing.
• Perform GD & T evaluations on tolerance stack ups.
• Conduct component validations at suppliers and internally, including writing comprehensive protocols and reports based on statistical analysis.
• Present supplier performance metrics, including defect rates, trending data, and quality throughput.
• Lead and collaborate with suppliers in a timely manner to address quality issues and non-conformances, driving implementation of process improvements through SCAR’s.
• Maintain an updated supplier performance database
• Oversee product, component, assembly and process qualifications at suppliers.
• Report discrepancies and positive/negative trends to management to drive process improvements.
• Participate in the review of engineering specifications to ensure that adequate requirements are met.
• Review drawings for adherence to design inputs; material callouts and standards and procedures; and regulatory and QS requirements; verify that required reports are attached so that the project can proceed to the next phase.
• Support QMS systems and organizational growth, including participation in MRB meetings, Batch reviews, product release, and CAPA investigations.
• Prepare and present detailed reports on quality metrics, supplier performance, and corrective actions.
• Perform other job duties as assigned by management.

Minimum requirements

• Bachelor’s degree in Mechanical Engineering, Engineering, Quality Management or a related field, or equivalent related experience.
• Minimum 10 years of experience with software driven electronic medical devices.
• In depth experience in Quality within a medical device manufacturing environment with expertise in cGMP, QSR, ISO, MDD, and MDR regulations.
• Minimum 3 years of experience in supplier audits and supplier qualification implementation.
• Certifications such as Six Sigma Green/Black Belt or ASQ Certified Quality Engineer (CQE) a huge plus.
• Strong knowledge of ISO 13485, FDA QSR Part 820, and EU MDR.
• Experience with alternative Quality related tools (D and P, FMEA, QFD, SPC, Risk Analysis, DOE, and TQM) also a plus. Proficiency in Microsoft Word, Excel and Outlook, Visio, PowerPoint Visual Basic, Access, and Mini-Tab or other comparable statistical analysis software application.
• Familiar with investigational tools such as 5-Whys, Fishbone Diagrams, Turtle Diagrams, etc.
• Detail-oriented and organized in meetings and reviews.
• Strong understanding of statistical methods.
• Strong ability to write reports, business correspondence, and procedure manuals.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Proven project management skills; able to complete technical projects on time and with limited supervision.
• Have organizational, communication skills and the ability to perform varied tasks in a disciplined, consistent manner.
• Ability to work individually or within a Team in a fast-paced and team environment.
• Experience with sterilization validation (gamma/EO), design controls, and statistical analysis
• Familiarity with Class II/III medical devices
• Hands-on experience with electromechanical devices, software validation, and sterile disposable