Quality Engineer

Tela Bio Inc • Malvern, PA

6h • Hybrid

About The Position

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 TELA Bio manufactured and distributed products. 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, change controls, non-conformances, investigations, and corrective/preventive actions).

Requirements

• Bachelor’s degree in scientific (biology, chemistry, biochemistry, physics, etc.) or engineering discipline
• 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
• Ability to multi-task, work in a fluid environment, manage time efficiently, achieve goals with minimal supervision, and effectively interact with other employees, departments, service providers, and development/manufacturing partners
• 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
• Must be able to: multi-task in high pressure, changing conditions.
• carry and lift to 25 lbs.

Nice To Haves

• Certifications, such as CQE, CQA, are a plus
• Lead auditor experience and/or experience interacting with regulatory agencies, a plus
• Knowledge of basic statistical methods, test method validation, equipment installation, qualification, and validation preferred, but not required

Responsibilities

• Continually improve existing quality systems to achieve or maintain conformance to 21CFR820, ISO 13485, EU MDR 2017 and other applicable regulations; areas may include CAPA, NCR, Change Control, Identification/Traceability, Document Controls, Acceptance Activities, Customer Complaints, Inspection and Release, Validations
• Serve as the Quality function on Process Validations and Verifications including collaborating/reviewing/approving IQ, OQ, PQ, Computer System Validation, and other related documents
• Manage the TELA Bio Internal Audit Program
• Serve as Quality Event leader (e.g. CAPA coordinator, Change Control Coordinator, etc.), assuring timely completion of Quality Events by all applicable TELA Bio employees
• Assist in supplier management including assessment, audit (if necessary), and supplier corrective actions
• Create and maintain quality systems documentation such as quality manual, procedures, work instructions, and forms
• Manage the complaint handling process including reporting to regulatory authorities, as required
• Participate in regulatory inspections

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees