Be an early applicantLess than 25 applicants

Company

Original Job Post

Smith+Nephew · 5 days ago

Senior Quality Engineer

Columbia, MD

Full-time

Hybrid

Senior Level

5+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

BiotechnologyHealth Care

H1B Sponsorship

Comp. & Benefits

Insider Connection @Smith+Nephew

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Provides support for New Product Development and market expansion. Strong background in Medical Device Design Control and Risk Management is a must.

Performs non-conformance and CAPA investigations to determine root cause and drive corrective actions.

Writes, reviews, and executes validation protocols, reports, and other technical studies as required.

Performs data analysis using statistical tools, including trending and sample size determination.

Performs risk assessments including Hazard Analysis and FMEA applying standards such as ISO 14971.

Provides technical and quality support for various validation projects including shipping studies, stability studies, clean room validations, equipment validations, cleaning validations, and process qualification.

Writes Standard Operating Procedures and Change Controls as required.

Works independently and provides leadership to manufacturing technicians and other executors of authored protocols.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Medical device R&DQuality assuranceQuality controlQuality engineeringMedical product designManufacturing qualityShop floor controlQuality management systemsDesign controlRisk managementProcess validationDesign quality21 CFR 820ISO 13485Applicable quality system regulationsStatistical softwareExcelMiniTabMicrosoft programsWordPowerPointVisioTechnical writing WindowsMicrosoft Office ApplicationsProblem-solvingHard-working communicationOrganizational skillsTime management

Required

Minimum of a Bachelor of Science degree in Engineering or scientific field required

5 years of experience in medical device R&D, Quality Assurance, Quality Control, and/or Quality Engineering environment

Competence in both medical product design and manufacturing quality is essential, including shop floor control and manufacturing quality engineering

Competence in quality management systems - design control, risk management, process validation, design quality, 21 CFR 820, ISO 13485

Working knowledge of applicable quality system regulations including US, EU, and other major global/regional standards for tissue and/or medical device products

Fluent in statistical software (Excel, MiniTab, R); Fluent in Microsoft programs (Word, Excel, PowerPoint, Project and Visio), Strong written and verbal communication skills

Excellent organizational and time management skills

Excellent verbal and written communication skills

Ability to work independently

Technical writing

Proficiency in Windows and Microsoft Office Applications (i.e., Word, Excel, Outlook, MS Teams)

Physical Requirement: Office area and manufacturing shop floor exposure, be able to lift 25 lbs infrequently

Preferred

Licenses/ Certifications: CQA preferred

Familiarity with human tissue regulations a plus

Ability to perform software programming (R, SQL, C++) preferred

Benefits

401k Matching Program

401k Plus Program

Discounted Stock Options

Tuition Reimbursement

Medical

Dental

Vision

Health Savings Account (Employer Contribution of $500+ annually)

Employee Assistance Program

Parental Leave

Fertility and Adoption Assistance Program

Company

Smith+Nephew

Glassdoor

4.1

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living.

Founded in 1856

London, England, GBR

10,001+ employees

https://www.smith-nephew.com/en

H1B Sponsorship

Smith+Nephew has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (31)

2022 (76)

2021 (73)

2020 (52)