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Principal Quality Engineer/Manager

Biomedical Resource Consultants, Inc.

Principal Quality Engineer/Manager

Boston, MA
Full Time
Paid
  • Responsibilities

    Principal Quality Engineer/ Manager

    Position Summary: As a Principal Quality Engineer/ Manager you will provide technical leadership daily by developing, establishing, and maintaining quality engineering methodologies, systems, and practices which meet world class standards.

    Among other tasks you will investigate non-conforming events and product failures to drive product/process improvements with the objective of compliance safety and high customer satisfaction.

    Serve as a multi-functional team leader for quality improvement teams assuring commitments and objectives are achieved with positive results. In addition, evaluating process methods and equipment to meet performance and quality requirements. Establishing quality plans for equipment and processes for general and specific product performance needs.

    You will apply QSR requirements to processes and procedures for our company and outside suppliers; Working with suppliers on new product introduction to ensure that quality and performance requirements are fulfilled.

    You will assist Manufacturing, Sourcing and Development in the interpretation and application of regulations and develop and maintain department and project budgets.

    Primary Responsibilities:

    • Must be able to interface well with management, Manufacturing Engineering and R&D Engineering.

    • Provide coordination and guidance to cross functional teams to ensure product quality objectives are met.

    • Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, Health Hazard Evaluations, etc.

    • Manage Quality Inspection group and Quality Engineer(s) regarding efficiency, improvement, priorities, and strategy.

    • Develop, implement, and monitor quality metrics and communicate status and progress.

    • Develops systems for monitoring manufacturing quality. Recommends and assists, as necessary, in the implementation of corrective/preventative actions.

    • Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.

    • Develops and implements quality programs, including tracking, analyzing, reporting and problem solving.

    • Lead problem-solving teams through root cause investigations and failure analysis to implementation and final verification.

    • Develop validation strategies so that all appropriate requirements are being met from planning, protocol definition, leading execution of protocol, analyzing and reporting results and defining procedures and training requirements, completing report and gaining approval to close.

    • Participate in the development and results analysis of validation plans (IQ/OQ/PQ) and test protocols to qualify and validate existing and new product designs and processes. Includes the use of various statistical techniques and quality tools.

    • Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.

    • Lead and support test method validations plans/protocols and reports.

    • Support computer system validations for manufacturing and test equipment. •

    Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will assure specific quality levels.

    • Lead the non-conforming material process and participate in or lead the Materials Review Board.

    • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.

    • Ability to deliver, meet deadlines and be results oriented.

    • Plan and provide support for FDA and other governmental or ISO Notified Body inspections, including pre- and post-inspection support, as requested. Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.

    Key Requirements:

    • Typical experience required is a minimum of 8 years as an Engineer in the related field or a combination of equivalent education and relevant experience along with supervisory/management experience.

    • BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline, preferred.

    • Highly motivated and self-directed with a strong sense of urgency, with an ability to pull in resources from other departments as required.

    • Product design engineering experience of low to medium volume manufacturing of electro-mechanical products highly desirable

    • Able to use and instruct others in the use of MSA (GR&R), Statistical Analysis, Cp/Cpk studies, Control Plans, CAPA, etc

    • Working experience in GDT and design for assembly/manufacturability of complex assemblies highly desirable

    • Critical Thinking, see the big picture and drill down to the components of it.

    • Excellent Communications (oral, written, presentation) Skills at different organizational levels

    • Leadership Skills/Soft Skills

    • Solid experience in Risk Management for medical devices ISO 14971desired • Application and leading problem-solving and root cause analysis.

    • Regulated industry preferred

    • Proficient in the use of various measuring tools and troubleshooting equipment

    • Facilitates team efforts on quality engineering projects.

    • Highly skilled with root cause analysis tools and methods.

    • Highly skilled with defect avoidance methodologies such as poke yoke, DFMEA/PFMEA, DOE

    • Knowledge and ability to apply regulatory requirements including FDA, ISO and EU MDR.