Quality Engineer

Overview

Position Title:
Quality Engineer - Onsite - Malvern, PA

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).

• Lead quality control (QC) and quality assurance (QA) activities.
• Develop inspection and release specifications and requirements for TELA Bio manufactured and distributed products.
• Manage identification and traceability processes.
• Support equipment control.
• Direct or participate in the completion of quality events (validations, change controls, non-conformances, investigations, and corrective/preventive actions).
• Continually improve existing quality systems to achieve or maintain conformance to 21 CFR 820, 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, and 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), 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 system documentation such as the quality manual, procedures, work instructions, and forms.
• Manage the complaint handling process including reporting to regulatory authorities, as required.
• Participate in regulatory inspections.

• Bachelor's degree in scientific (biology, chemistry, biochemistry, physics, etc.) or engineering discipline.
• 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.
• Lead auditor experience and/or experience interacting with regulatory agencies, a plus.
• 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 (Master Control) and/or ERP software (Sage), a plus.
• Knowledge of basic statistical methods, test method validation, equipment installation, qualification, and validation preferred, but not required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to: multi-task in high pressure, changing conditions; carry and lift to 25 lbs.

This position primarily works in the corporate office or home office location. The noise level in the work environment is quiet to moderate.

The position may be hybrid (preferred) or remote, with minimal travel required.

This is a representative description of the job and is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization. Duties, responsibilities, and activities may change at any time with or without notice. TELA Bio, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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