Position Summary

Reporting to the Senior Manager or Director of Quality, the Quality Engineer will have responsibility of ensuring that processes and products consistently meet established quality standards. While ensuring compliance to internal quality system and applicable regulations, the quality engineer will monitor and improve the quality of operational processes and outputs. His/her/their range of responsibilities will entail designing quality standards, inspecting materials, equipment, processes, and products, developing quality control systems, and determining corrective actions.

Qualifications

Bachelor's degree in engineering, biomedical engineering or related scientific discipline.
3-5 years’ experience working in manufacturing of finished medical device or related industry.
Working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, and the EUMedical Device Directive.
Lead auditor credentials for QSR, ISO, or MDSAP are desired (ASQ Certification preferred).

Responsibilities

The range of responsibilities includes but not limited to developing and implementing quality standards, monitoring and analyzing quality performance, inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met; collaborating with cross-functional teams to develop and implement controls and drive improvements, ensuring that workflows, processes, and products comply with safety regulations, investigating and troubleshooting product or production issues, developing corrective actions, solutions, and improvements; reviewing specifications, and processes. The senior quality engineer may assume leadership role leading projects and teams, even strategizing, championing, motivating and ensuring all teams receive the appropriate information and guidance.

Technical

Develop and maintain quality systems and documentation in compliance with FDA, ISO, and EUMDR requirements.
Lead and/or support on-time completion of design control deliverables for both new product introductions and design change projects.
Support design verification/validation planning and execution, including any cross-functional investigation and resolution activities.
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.
Lead risk management activities from product concept through commercialization.
Support Product development activities and design transfer into manufacturing.
Support Manufacturing Engineering in the creation, release and maintenance of DHR/LHR, bills of material, and specifications for manufacturing.
Assist in the selection, qualification, and assessment of new suppliers based on established procedures.
Conduct supplier audits to evaluate their capabilities, processes, and quality management systems.
Develop establish and maintain periodic reviews with suppliers on their performance(scorecards), and improvement or corrective action plan(s).
Support nonconforming material investigation and disposition activity, participate in weeklyMRB meetings, follow-up on supplier issues.
Assist with maintenance of calibration system.
Perform incoming inspection review and disposition of product components and subsystems.
Assist in investigations of quality issues arising from product complaints, CAPAs, and non-conforming reports.
Utilize problem solving tools to analyze and identify root causes and implement corrective actions.
Actively participate in the Doc-Control process.
Support the Environmental monitoring process.
Initiate /approve validation protocols and reports (IQ, OQ, PQ).
Initiate /approve process validation protocols and reports.
Other duties and responsibilities as mutually agreed.

Leadership/Communication/Compliance Be an advocate for quality and create a culture of quality.

Be responsible in whole or in part for the effective manufacture of medical devices, compliance with internal policies/procedures and applicable regulations, and the efficient execution of related activities.
Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service to both internal and external customers.
Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
Act as the QA representative in cross-functional team meetings, MRB, new product introductions, and supplier quality meetings.
Make decisions and propose solutions based on calculated risks identified through data analysis.Process Customer Complaints and manage customer replies
Champion continuous improvement through CAPA system, handling of complaints, analyzing key performance indicators. Support activities associated with Sterilization and Biocompatibility
Assist in training personnel to processes associated with design and development and manufacturing.

Attributes

Attention to Detail and Cognitive Skills working on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Candidate must be highly motivated with excellent communication skills and proven ability to work as part of a team.
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
Strong documentation capability for protocol and report generation and review. Ability to work ina rapidly changing and evolving environment.

• Prior start-up experience is a plus.

Physical Demands

Business travel from 0% - 25%. Requires some lifting and moving of up to 40 pounds. Required to frequently stand, walk, sit, and use a computer for extended periods. Specific vision abilities required by this job include, close/distant vision and depth perception. Position also requires use of Personal Protective Equipment as needed

Advanced Bifurcation Systems Inc.

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Advanced Bifurcation Systems Inc. | Quality Engineer, Senior Quality Engineer