Quality – Senior Quality Engineer

Company : Pioneer Data Systems

Country: United States

Location : Malvern, Pennsylvania

Post: Sat, 25 Mar 2023 06:27:57 GMT

Expires: Sat, 22 Apr 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Position Details:

Our client, a world-leading Pharmaceutical Company in Malvern, PA is currently looking for a Principal Quality Assurance Engineer / Medical Devices / REMOTE WORK to join their expanding team.

Job Title: Principal Quality Assurance Engineer / Medical Devices / REMOTE WORK

Duration: 12 months contract, extendable up to 24 months

Location: REMOTE WORK (Work from home Eastern hours)

Client location: Malvern, PA

Note:

The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.

You may participate in the company group medical insurance plan

Job Description:

This position is being opened for 12 months to start with anticipation to extend through the tenure limit (24 months). Contractor will be responsible for providing their own equipment (i.e.: laptop) during engagement. Position will be remote but required to work Eastern Hours.

Principle Product Quality Engineer

Position Summary

Provide Quality Assurance/Engineering support and leadership to software product development, IT Implementation, and process improvement projects in Digital Solutions.

Primary focus on CGM product development and launch readiness

Regularly interface with project team members of product development, clinical operations, regulatory, V&V, IT, PMO, and other stakeholders to ensure that the Design control, IT Systems Software V&V, and Quality Management & Compliance processes are followed.

Provide leadership and support for inspection readiness program to ensure Digital Solutions and their products are inspection ready.

Escalate to management and delegate as required.

Major Duties & Responsibilities:

Quality Assurance (Product)

Execute and serve as the subject matter expert in quality assurance and process management related activities in the development of new digital products and software management processes. Represent the mindset and principles of the Quality department and drive quality initiatives. Assure adherence to quality systems to achieve highest levels of compliance.

Lead quality activities in projects and product teams in the medical device realm and executes activities like product risk management, privacy & information security risk management, process compliance monitoring, supplier quality management, change management.

Utilize effective and efficient Quality Engineering techniques such as risk analysis, test method development, design of experiments, statistical data analysis, and development of sampling plans throughout the product lifecycle to execute associated tasks in Quality Engineering

Ensure product lifecycle deliverables meet the requirements of LifeScan’s processes, regulatory reviews, and pass internal and external audits. Ensure audit follow-ups and findings are appropriately addressed promptly.

Responsible for compliance to the LifeScan Quality System and applicable regulations.

Quality Systems and Compliance

Drive implementation of Global LifeScan Quality System within Digital Solutions and associated partners.

Provide management support for quality systems and compliance activities for associated areas (Field Action Evaluation and resulting field actions, Non-Conformances, CAPA, Audits etc.).

Lead significant activities within the quality system such as: change control, NC, CAPA, supplier monitoring, risk management activities, involving global or highly complex interactions.

Oversee Digital Solutions suppliers and ensures they are managed per LifeScan processes.

Participate in project teams as required to represent Quality.

Maintain awareness of industry issues, trends and changes in quality regulations and policy and bring those to the attention of management.

Quality Assurance (IT Systems V&V Process)

Lead IT Systems validation programs and oversees the adherence to LifeScan validation processes and methodologies and medical devices industry best practices.

Work with stakeholders and suppliers to ensure high quality, process compliant, and timely commissioning of IT systems.

Identify and implement ways to make the processes efficient while ensuring compliance.

Key Experiences / Functional Knowledge Requirements:

Bachelor’s Degree in engineering/scientific or associated relevant technical discipline

8-10 years of experience in the Medical Device/Pharmaceutical/Consumer Healthcare or regulated industry

Expertise in Software Development Lifecycle in Agile and Software as a Medical Device

Expertise in Quality Systems, Quality Assurance, and/or Regulatory Affairs in a Pharmaceutical or Medical Device GMP/ISO environment

Design Controls

Risk Management

Strong investigative and analytical skills, data driven decision making, failure investigation, and Root Cause Analysis

Proactive approach to issue identification and problem resolution

Change Management, specifically as related to Software as a Medical Device

Administrating and troubleshooting regulated QMS applications

Proficient in MS Office product suite and Atlassian suite (JIRA, Confluence etc.)

Experience in electronic QMS

Desirable:

Advanced degree in engineering/scientific or associated relevant technical discipline

Previous experience in a Senior/Leadership role

External audit experience (Notified Body, FDA, etc.)

Certifications in project, change, and/or process management (Lean, Six Sigma, PMP, etc.)

Certifications in Quality and/or auditing (ex. CQE, CQM, CSQE, CQA, etc.)

Role Specific Competencies:

Working knowledge of Quality Management System standards and regulations

Knowledge of FDA regulations (21 CFR 820, cGxP, 21 CFR Part 11), EU MDR, ISO standards (9001, 13485, 14971, 27001), IEC 62304, HIPAA, GDPR, etc.

Medical Devices and Software as a Medical Device manufacturing, distribution, and reporting.