Quality Engineering Manager

Watertown, MA /
Quality /
Full-time
Are you interested in an engaging job and making a big impact in patient's lives?


Summary:
Windgap Medical, Inc. is a rapidly growing, private company developing injection devices for self-administration of pharmaceutical compounds. Windgap’s first product is a wet/dry autoinjector for the delivery of epinephrine for the treatment of anaphylactic shock. Long-term, Windgap is leveraging its injectable platform and IP for other indications beyond epinephrine. 

Job Description:
As an integral member of the quality team, the Quality Engineering Manager will work to ensure compliance with 21 CFR 210, 21 CFR 211, 21 CFR 820 / ISO 13485, 21 CFR 4 and ISO 14971 during all projects and activities. This position collaborates closely with product development in design quality assurance/engineering activities. This includes design control, quality planning, risk assessments/analysis/management/reporting, design reviews, and design verification/validation. The position will also participate in design transfer activities such as process validation, equipment qualification, and other manufacturing activities. This position is critical to bring new products to market and ensures compliance throughout the product life cycle. This is an opportunity for an experienced quality engineer to apply their knowledge and clearly see the benefits realized from their individual contribution in the ongoing improvement and management of the Quality Management System. The Quality Engineering Manager will work with the Quality Systems Manager to ensure that all aspects of quality are appropriately specified, executed upon, and documented, consistent with best practices.

The candidate will:

    • promote and uphold a culture of quality, customer focus and operational excellence
    • support cross-functional initiatives to maintain the effectiveness of Windgap’s Quality Management System including the development of procedures and participation in audits
    • support and participate in management reviews through provision of QC key performance indicators/metrics
    • lead design verification and validation activities, including planning, protocol development, analysis of results and reporting
    • perform quality reviews and approvals of technical documentation for design and development, including, but not limited to engineering change orders, drawings, tolerance analyses, verification and validation protocols/reports
    • lead/support Risk Management activities from product Concept through Commercialization including, planning, analysis, evaluation, and reporting throughout the life cycle of products
    • develop and maintain Windgap’s use, design, process and application risk assessments such as failure mode effect analysis
    • manage cross-functional root-cause analysis investigation & resolution activities
    • design, document and implement methods for process control, process improvement, and testing
    • develop and maintain statistically sound, risk-based sampling plans and perform data analysis
    • develop objective, measurable, discrete, and verifiable product quality specifications, sampling plans, and communicate with vendors on these specifications/plans
    • responsible for execution and/or management of process validation efforts including IQ/OQ/PQ activities
    • manage and/or support design of experiments efforts by Windgap and its partners
    • evaluate, monitor, develop, and implement standards and methods for inspection, testing, and evaluation of processes and products to meet engineering and customer requirements
    • responsible for execution and/or management of biocompatibility and sterilization qualifications
    • maintain awareness of current regulations and standards and assist in their effective implementation throughout the quality management system
    • perform post-market surveillance research and report on results to Company stakeholders
    • support cross-functional initiatives to maintain the effectiveness of Windgap’s Quality Management System including the development of procedures and participation in audits
    • support objective component specification definitions, supplied component sampling plan development and vendor qualifications
    • support and participate in management reviews through provision of QC key performance indicators/metrics
    • prepare and participate in the Material Review Board (MRB), including the analysis of NCMR trend data
    • maintenance of equipment calibration program
    • manage the CAPA process as a CAPA owner, including root cause analysis/investigation, risk evaluation of corrective actions, and revision of risk documents and tables
    • assist in FDA and ISO audits and internal audits as necessary
    • report to the Company CEO

Relevant experience:

    • 5+ years in quality engineering role in medical devices
    • B.S. in engineering (Mechanical or Biomedical preferred)
    • Strong knowledge of 21 CFR 4, 21 CFR 210, 21 CFR 211, 21 CFR 820 / ISO 13485, ISO 14971 
    • Detail-oriented, results-based and self-motivated
    • History of successfully serving as quality representative on product development teams
    • Strong interpersonal communication skills, ability to work in team environment, and excellent organizational skills
    • Operational experience with software-based quality and regulatory systems, preferably MasterControl
    • Experience in a start-up environment, requiring flexibility along with the ability to seek out and quickly assimilate new information
    • Experience in interfacing with large pharmaceutical and medical device companies
    • Working knowledge of SPC, Design of Experiments and Gage Repeatability and Reproducibility studies
    • Preferably, ASQ Certified Quality Engineer (CQE)
    • Preferably, experience with combination products and/or drug delivery
    • Preferably, demonstrable project management and costing experience
    • Preferably experience with statistical analysis and statistical tools such as Minitab, SPSS, Statistica or JMP
    • Proficient in Word, Excel and PowerPoint
    • Experience with CAD, SolidWorks preferred
Windgap Medical, Inc. offers a competitive benefits package including, medical, dental, disability, life insurance, 401K savings plan and is EOE/M/F/D/V employer. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Thank you for considering Windgap Medical. We will review your qualifications and contact you if we would like to talk more.

Sincerely,

The Windgap Medical Team