Staff Quality Engineer

Staff Quality Engineer

Job Title Staff Quality Engineer FLSA Salaried Exempt Department Operations and Quality Reports To Senior Quality Manager Download the job description

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Job Responsibilities:

In this role, there will be a significant focus on production quality. This will include supporting in-process inspection, final inspection, final product release activities, will lead investigation and resolution of nonconformances, and own production risk documentation.

Ideal candidates will have direct experience with product line support in a medical device manufacturing environment (preferably Class III). This role requires active engagement with day-to-day production activities alongside Operations Engineers, Supervisors, and production personnel.

Direct experience with process and equipment qualification / validation, sterile barrier packaging, labeling, and ethylene oxide (EtO) sterilization processes is preferred.

At the Staff Level, candidates should have demonstrated experience working in Medical Device Quality Systems, Risk Management, and have working knowledge of several other areas including Design Controls, Statistics, and Regulatory Requirements for medical devices.

General Description and Duties:

To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Production: Develop and implement quality inspection procedures including sampling plans, for production level components, sub-assemblies and finished goods. May also be responsible for the development and implementation of inspection methodologies, fixtures, measurement systems and calibration of such. Lead investigations, disposition, and corrective action activities for product non-conformances.

• Process Verification and Validation: Provide input regarding appropriate statistical methods, test methodologies, test facilities and equipment. Coordinate testing and manage resulting documentation. This can include process validation, equipment installation/operational qualification, test method validation, etc.

• Documentation: Create, review, and approve controlled documents on an electronic document control system (e.g. work instructions, quality specifications, engineering specifications, procedures and validation protocols and reports).

• Compliance: Ensures compliance with company quality policies and practices by participating in product and material reviews, assist in resolving problems related to the manufacture, test, validation, and documentation.

• Product Release: Review and approve lot history records and sterile load records to ensure product compliance with specifications and regulatory requirements. Provide support, guidance, education, and training to personnel. Ensure inspections, tests, and sterilization are performed in accordance with procedures.

Projects and Other Duties:

• Perform other duties as assigned.

Position Qualifications

• Experience and knowledge of regulatory requirements such as GMP's, ISO, etc.

• Knowledge of and ability to effectively use analytical tools and methods including statistics, DOE, and the use of computer software packages related to testing, data collection, calibration, etc.

• Strong understanding of medical device manufacturing processes, receiving inspection, in-process and finished device inspections, non-conforming material resolution, CAPA, and record keeping.

• Strong understanding of process validation, metrology, and inspection equipment.

• Strong communication skills (both written and verbal) required

• Ability to work independently or in team setting required.

Minimum Education:

• BS in Engineering or scientific discipline.

Minimum Experience:

• 7 - 9+ years of Quality experience within Medical Device or related industry. High risk and/or implantable medical device experience is highly preferred.

• Experience with an Enterprise Resource Planning systems, such as QAD, SAP, JD Edwards, etc. is preferred.

Salary:

Aligning our overall business objectives with performance and merit based pay, Axonics offers competitive salaries, performance-based incentives, and Employer paid benefits programs to address the diverse individual needs of our employees and their families. At Axonics, our employees come first!

For California, the base pay range for this position is $110,000 to $135,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Axonics is an Equal Opportunity Employer, included protected Veterans and individuals with disabilities.