35 applicants

Company

Original Job Post

Stryker · 1 week ago

Senior Quality Engineer

Durham, NC

Full-time

Onsite

Senior Level

2+ years exp

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BiotechnologyHealth Care

H1B Sponsorship

Actively Hiring

Growth Opportunities

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Responsibilities

Work closely with operations and the business functions to ensure quality performance of product and processes. (SGS)

Oversight of NC/CAPA, activist and mentor in problem-solving and root-causing activities.

Lead and participate in the development and improvement of the manufacturing processes for existing products. (SGS).

Review of change management activities.

Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.

Proficient understanding of risk management practices and concepts.

Develop and provide input by identifying opportunities and weaknesses.

Proficient in statistical methods and application.

Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audit preparation building confidence and proficiency in interactions.

Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes. (SGS).

Coach and mentor others in quality topics and activities.

Qualification

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Related ExperienceMSCQECREValidationSterilizationClean RoomGMPQMS Compliance AuditsRegulatory Agencies InteractionFDAMoHTUVUS Medical Device RegulationsInternational Medical Device RegulationsISO 13485GDPRisk ManagementCAPAAuditsStatisticsCompliance Risk SituationProblem-SolvingHighly Developed

Required

Bachelor’s degree in a science, engineering or related discipline required.

2+ years of related experience.

Preferred

MS, CQE, or CRE preferred.

Previous industry experience desired (Validation, Sterilization, Clean Room GMP, QMS Compliance Audits).

Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.

Understanding of US and International Medical Device Regulations.

Familiarity with ISO 13485, GDP, GMP desired.

Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).

Demonstrated ability to work independently and as part of cross-functional teams.

Experience in working in a compliance risk situation.

Highly developed problem-solving skills

Benefits

Medical and prescription drug insurance

Dental insurance

Vision insurance

Critical illness insurance

Accident insurance

Hospital indemnity insurance

Personalized healthcare support

Wellbeing program

Tobacco cessation program

Health Savings Account (HSA)

Flexible Spending Accounts (FSAs)

401(k) plan

Employee Stock Purchase Plan (ESPP)

Basic life and AD&D insurance

Short-term disability insurance

Company

Stryker

Glassdoor

4.1

Stryker is a medical technology company that offers products and services in orthopaedics.

Founded in 1941

Kalamazoo, Michigan, USA

10,001+ employees

http://www.stryker.com/en-us/index.htm

H1B Sponsorship

Stryker 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 (36)

2022 (76)

2021 (73)

2020 (69)