Quality Engineer

Job Description

Quality Engineer

The Quality Engineer is primarily responsible for leading quality control (QC) and quality assurance (QA) activities. Key responsibilities within the QC function include development of inspection and release specifications and requirements for the company’s manufactured and distributed products.

This position reports to the Quality Manager as an onsite position.

Key responsibilities within the QA function include managing identification and traceability processes, supporting equipment control, and directing or participating in the completion of quality events (validations, design controls, change controls, non-conformances, investigations, and corrective/preventive actions).

Responsibilities:

• Continually improve existing quality systems to achieve or maintain conformance to 21CFR820, ISO 13485, EU MDR (2017/745) and other applicable regulations; areas may include CAPA, NCR, Change Control, Identification/Traceability, Document Controls, Acceptance Activities, Customer Complaints, Inspection and Release, Validations.
• Write and implement quality processes including policies, SOPs, Work Instructions, and Forms. Ensure that new and updated processes are holistically integrated into the company’s Quality Management System.
• Serve as the Quality function for Process Validations and Verifications including collaborating on/reviewing/approving IQ, OQ, PQ, Computer System Validation, and other related documents.
• Provide medical device design control guidance to Product Development team and cross functional team members as needed.
• Assist with the company’s Internal Audit Program.
• Complete Quality Events, assuring timely completion, as needed (e.g., CAPA, NC, Change Control, etc.),
• Assist in supplier management including assessment, audit (if necessary), and supplier corrective actions.
• Manage the complaint handling process including complaint intake, communications, documentation, and investigation. Coordinate with Regulatory to complete reporting determinations and reporting to regulatory authorities, as required.
• Participate in regulatory inspections.

Requirements:

• Bachelor’s degree in a scientific or engineering discipline (biology, chemistry, biochemistry, physics, etc.)
• ASQ Certifications, such as CQE, CQA, are a plus.
• Minimum 3-5 years in a regulated industry, medical device experience preferred.
• Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485:2016 requirements and related standards.
• Audit experience and/or experience interacting with FDA and Notified Bodies, a plus.
• Ability to work in a fluid environment and manage time efficiently while working independently and part of a team.
• Ability to develop, implement, maintain, and improve processes and procedures which support the quality system.
• Ability to analyze data and justify the statistical technique and sample sizes used.
• Knowledgeable on all Microsoft Office Applications (Word, Excel, PowerPoint, Visio), Adobe Pro, and Minitab; familiarity with an electronic document management system (MasterControl) and/or enterprise resource planning software (Sage) a plus.
• Knowledge of basic statistical methods, test method validation; equipment installation, qualification, and validation