Quality Engineer

Position Title: Quality Engineer - Onsite - Malvern, PA 

 

Position Overview

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). 

 

Essential Duties and 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, ValidationsServe as the Quality function on Process Validations and Verifications including collaborating/reviewing/approving IQ, OQ, PQ, Computer System Validation, and other related documentsManage the TELA Bio Internal Audit ProgramServe as Quality Event leader (e.g. CAPA coordinator, Change Control Coordinator, etc.), assuring timely completion of Quality Events by all applicable TELA Bio employeesAssist in supplier management including assessment, audit (if necessary), and supplier corrective actionsCreate and maintain quality systems documentation such as quality manual, procedures, work instructions, and formsManage the complaint handling process including reporting to regulatory authorities, as requiredParticipate in regulatory inspections 

Education and Experience

Bachelor’s degree in scientific (biology, chemistry, biochemistry, physics, etc.) orengineering discipline

Certifications, such as CQE, CQA, are a plus 

Required Knowledge, Skills and Abilities 

Minimum 3-5 years in a regulated industry, medical device experience preferredStrong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485:2016 requirements and related standardsLead auditor experience and/or experience interacting with regulatory agencies, a plusAbility 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 partnersAbility to develop, implement, maintain, and improve processes and procedures which support the quality systemAbility 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 plusKnowledge of basic statistical methods, test method validation, equipment installation, qualification, and validation preferred, but not required  

Physical Demands

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. 

Working Conditions

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

 

Primary Location and Travel

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

 

Disclaimers

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. For more information, please check out our website: www.telabio.com

 

Equal employment opportunity, including veterans and individuals with disabilities.

PI281589757