Principal Quality Assurance Specialist

Inflammatix seeks a Principal Quality Assurance Specialist to support the Quality Management System. This person will work to ensure that the Inflammatix Quality System maintains compliance with FDA and all other U.S. and international regulatory requirements for Medical Devices and/or In-Vitro Diagnostics. The Principal Quality Assurance Specialist will be responsible for supporting the Quality Assurance function, equipment, and processes, as well as supporting internal & external audits, exception management processes, change management, and other QMS initiatives. The successful hire will be self-directed under general instructions and drive continuous improvement of the quality management system. This position reports to the Head of Quality Assurance.

Responsibilities



The Principal Quality Assurance Specialist will be accountable for the following activities:

Assist with Quality Management Systems processes as needed:

• Provide a wide variety of activities to ensure compliance with applicable quality and regulatory requirements.
• Develop, maintain, and perform Incoming quality control inspection processes.
• Track and facilitate investigations in cross functional team discussions in support of closing NCRs, deviations, and CAPAs.
• Support and prepare Quality Ops data for Quality Management Review.
• Manage and maintain Equipment system: calibration and PM schedules of all equipment, create equipment files, assign EQ numbers, review calibration certificates, assist in IQ/OQ/PQ.
• Set up and maintain IQC processes and procedures.
• Perform final inspection of subassembly, finished parts, and formulations.
• Develop and work with cross-functional teams to develop requirements for components.
• Assist and support internal/external audits of QMS processes to verify compliance with FDA QS, ISO 13485:2016 and other applicable requirements.
• Set up, write procedures for Instron and Micro-Vu.
• Support and/or administer training program and DCOs.
• Work cooperatively in a team environment to maintain cross-functional and cross-site processes and procedural consistency for quality system records.
• Analyze non-compliance issues to identify trends and propose resolutions.
• Support cleanroom environment monitoring and quality control data review.
• Review and approve manufacturing production documentation LHR/DHR to ensure product quality as well as GDP and completeness.
• Participate in projects that support continuous improvement efforts.
• Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.
  
  

MINIMUM QUALIFICATIONS

• Associate degree (Bachelor's preferred) preferably in engineering, a physical or biological science, or other technical field; or 15+ years of related experience in lieu of degree
• 5+ years of practical, hands-on experience in Quality Management Systems (10+ years preferred)
• Experience with document control (including EDMS), training, change control, deviations, nonconformance handling, CAPA, internal and external QMS audits, complaint handling, and other quality processes
• Experience working in an FDA-regulated environment; familiarity with ISO 13485 (preferred)
• Experience with new product development (preferred)
• IVD experience (preferred)
  
  

KNOWLEDGE, SKILLS, & COMPETENCIES

• Excellent problem-solving skills; demonstrated strength in utilizing tact and diplomacy with internal and external collaborators
• Ability to work independently and exercise good judgment
• Excellent written and communication skills
• Excellent interpersonal skills and ability to work on teams and with others in a positive and collaborative manner
• Excellent prioritization and organizational skills
• Experience with the Microsoft Suite of programs: (e.g., Word, Excel, PowerPoint, Outlook, etc.)
• Familiarity with electronic ERP systems (such as Sage)
  
  

COMPENSATION AND CLASSIFICATION:

Classification: Full-time

Compensation: Competitive and commensurate with experience; includes equity package

The base salary range for this position is $ 147,000 - $170,000 per year, which represents the low and high end of the anticipated salary range for this exempt position.

• Please note that actual offer will vary based on factors including, but not limited to the candidate's geographic location, job-related knowledge, skills, and experience among other factors including internal equity. As such, there is the possibility that the final, agreed-upon base salary may be outside of the lower or upper end of the range. Please also note the compensation range listed is just one component of the company's total rewards package. A bonus and/or long-term incentive units may be provided as part of the total compensation package, in addition to the full range of medical, financial and/or other benefits, dependent on the level and position offered.
• U.S. employees are offered medical, dental and vision insurance, as well as access to HSA, FSA, commuter, LTD, STD and basic life insurance. Employees are eligible to enroll in our company 401k plan and employer match. Employees accrue up to 15 paid vacation days, 7 paid sick days and 10 paid holidays per calendar year. Inflammatix U.S. offices are closed for winter break each year between Christmas and New Years Day and the company offers this time as additional paid time off for U.S. salaried/exempt employees.
• Benefits: Medical, dental, and vision; 401(k), generous leave and more
• Location: Sunnyvale, CA
  
  

 For travel, Inflammatix requires compliance with all applicable local and national health and safety guidelines.

Inflammatix is an equal opportunity employer and does not discriminate on the basis of race, ancestry, color, religion, sex/gender (including gender identity), pregnancy, childbirth, related medical conditions and breastfeeding, national origin, age, sexual orientation, marital status, registered domestic partner status, military and veteran status, physical or mental disability, medical condition, genetic characteristic, or any other characteristic protected by applicable law.

Notice to Agencies:

Our internal Talent Acquisition Team manages all career opportunities. Agencies and independent recruiters must be approved as a vendor by the Legal and Talent Acquisition teams at Inflammatix before submitting candidates (for any current or future positions) to any employee of Inflammatix. We do not accept unsolicited resumes or profiles from agencies or independent recruiters under any circumstances. Inflammatix will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume or profile. Please do not contact Inflammatix employees directly. Compliance with this request will impact our decision to engage or work with you or your agency and/or representatives in the future.