Sr. Quality Assurance Engineer
Analytics 4 Life (A4L) Inc is an innovative medical device company that is developing technologies for machine learning as well as diagnostics software and instrumentation products related to cardiac performance for use in physician and home settings. The company is developing and manufacturing products for commercialization in the United States, Canada, and Europe. A4L has offices in Toronto, ON Canada and in Morrisville, NC United States.
A4L Inc. is actively looking for an independent contributor as a Sr. Quality Assurance Engineer to implement, monitor and maintain an effective Quality Management System (QMS) and to ensure the performance and quality of medical devices produced conform to established standards and quality system regulatory requirements in markets where company products are distributed. This individual will be responsible for supporting product development activities, including risk management and V&V, provide quality support for operations, and perform tasks related to the management of quality system. Initial product development will be related to its first medical device products for detecting the presence of coronary artery disease and assessing cardiac function.
This position will report to the Kristine Canavan, VP Regulatory & Quality, and will be located at A4L’s Morrisville, NC office. The position will require travel, as necessary to the Toronto, ON office.
MAJOR DUTIES AND RESPONSIBILITIES (ESSENTIAL FUNCTIONS):
- Utilize Quality Engineering tools and principles to ensure product quality throughout the development, manufacturing and post-production lifecycle.
- Assist in the planning, coordination, execution and tracking of audits (External and Internal) to assure that the quality system is compliant with the quality system requirements.
- Under limited supervision, develop, implement, maintain and continuously improve processes and controls related to product quality for compliance with applicable standards and regulatory requirements, including International Organization for Standardization (ISO) 13485 and 14971, European Medical Device Directive (MDD 93/42/EEC), U.S. Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR).
- Support activities related to the Corrective and Preventive Action (CAPA) process, including investigating root cause(s) of nonconformities related to the product, processes and/or quality system; identifying actions(s) needed to correct or prevent recurrence; verifying and validating the action(s) to ensure effectiveness; implementing and recording changes to processes needed to correct/prevent nonconformities; disseminating information related to nonconformities to those directly responsible.
- Perform activities necessary to plan, implement, monitor and maintain auditing and certification activities (i.e. ISO 13485 certification).
- Support complaint investigation activities in compliance with standard operating procedures including Medical Device Reporting and Recall activities.
- Monitoring QMS for effectiveness and proposing improvements where necessary.
- Support the collection and analysis of Quality metrics including, but not limited to, complaints, CAPAs, manufacturing and supplier performance. Report to management, at defined intervals, during Management Review on the performance and effectiveness of the quality system, compliance with regulatory requirements and compliance with the established quality policy and quality objectives.
- Develop sampling plans based on valid statistical rationale and ensure sampling methods are adequate for their intended use.
- Provide A4L review and approval, as appropriate, receiving, in-process, and finish device acceptance.
- Provide A4L review and approval for disposition of nonconforming products (NCMR) identified by the contract manufacturer. Ensure appropriate retesting and reevaluation of the nonconforming product after rework to ensure that the product meets its current approved specifications.
- Support the Engineering / Operations team with the selection of external suppliers, contractors and consultants (as needed) to ensure that all purchased or received product and services conform to specified quality requirements.
- Provide support to Engineering / Operations to ensure compliance with production and process controls and Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and process validation.
- Support Operations and Contract Manufacturer with implementation of process controls and documenting of control methods and metrics (e.g. SPC, Cpk, Critical to Quality Attributes (CQA,) etc.
- Support Engineers with contract manufacturers including review of contract manufacturing and quality documentation, problem solving of manufacturing issues, and implementation of processes and/or corrective actions, as needed.
- Develop and implement continuous improvement for processes, equipment or workflow to improve product quality, manufacturing process efficiency and cost effectiveness.
- Train and support personnel in following the quality system and manufacturing procedures.
- Oversee development of Quality Agreements with critical suppliers and ensure adherence to quality agreement requirements.
- Support company continuous improvement programs to improve quality system metrics and implement new quality processes and techniques as required to meet company needs.
- Ensure compliance to processes and regulatory requirements related to medical device labeling, unique device identifier, medical device reporting, medical device reports of corrections and removals, and medical device recall
- Participate in hosting inspections by regulatory authorities (e.g., notified body, FDA and other regulatory agencies) and ensure all observations are appropriately addressed.
- All other tasks that may be assigned from time to time by management.PHYSICAL AND COGNITIVE DEMANDS:
- Must be able to hear, see and speak
- Must be able to move about the office and customer/prospect locations in diverse environments.
- Must be able to maintain a high level of consistent cognitive function to negotiate complex transactions within the organization and with suppliers.
- Must be able to effectively travel domestically and internationally up to 20% of working time including via automobile, commercial airliner and other forms of public transit.
- Must be able to tolerate diverse climatic conditions associated with travel and various locations.
QUALIFICATIONS & EXPERTISE:
- Background in manufacturing, operations or product development of medical devices.
- Experience coordinating and performing risk management, verification and validation of medical devices and implementation of inspection processes.
- Comprehensive knowledge of Medical Device regulations including FDA 21 CFR 820, ISO 13485, MDD 93/42/EEC and other applicable regulatory requirements.
- Comprehensive knowledge of IEC 60601-1 and related standards.
- Strong influencing and negotiation skills, project management skills, and ability to work well as a leader, independently and in a team setting.
- Excellent organizational skills, interpersonal skills and verbal and written communication skills with the ability to interface with executive management, other functions within the company, and consultants and vendors outside the company.
- Ability to exercise sound judgment and analyze and solve problems.
- Ability to multi-task, prioritize, plan and evaluate deliverables to established goals.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint).
- Ability to travel for external supplier audits, as needed (≤ 10% of the time).
- ASQ CQE and CQA Certifications or related quality/regulatory certification a plus.
- Experience with SDLC a plus.EXPERIENCE REQUIREMENTS: Minimum six years of experience in the medical device industry with hands on experience in developing and working with quality systems under the US regulatory requirements. Experience with supporting product development of electro-mechanical, with firmware, medical devices. EDUCATION REQUIREMENTS: Bachelor of Engineering degree (minimum)
Contact Information: Deborah Sarradet, Quality Director. Deborah.firstname.lastname@example.org