Overview
Quality Inspector Jobs in Fort Worth, TX at Data base Solution
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Job description
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits.
Stryker is currently seeking a Staff Internal Quality Auditor to join our global Quality Management Systems team. This is a full-time remote role based in the Central or Eastern time zone, requiring 40% travel.
As the Staff Internal Quality Auditor, you will be responsible for working collaboratively with key stakeholders from new and existing Global Quality and Operations (GQO) Stryker sites in the planning, execution and reporting of Internal Audits. You will quickly build strong relationships throughout Stryker’s global footprint. You must possess very strong written and oral communication skills and be able to report findings throughout all levels of the organization in a collaborative and fact-based manner that is conducive to building strong partnerships. A keen understanding of the highly regulated environment, great attention to detail, and the ability to make important decisions independently are requirements of the position.
What you will do
Lead Internal audits independently from planning, execution, closure, reporting, and post-audit follow-up
Plan and tailor the audit agenda and scope based on feedback and information received from the site being audited
Interpret and provide guidance on applicable regulations such as FDA, ISO, MDD and Stryker policies
Assist in the coordination of Stryker Internal Audit program to ensure compliance to quality system requirements
Present audit results and correlating data to key stakeholders at the site location
Escalate emerging trends of audit findings to identify areas for improvement
Interface with Site RAQA Heads, GQO Quality Management and International RAQA Management, where applicable
Monitor observations from external and Corporate quality audits of Stryker sites
What you need
Required
Bachelor’s degree
Professional certification in Quality Auditing (i.e. Certified Lead Auditor)
4+ years medical device or FDA regulatory industry experience
2+ years Quality Audit experience (internal, external, and/or supplier)
Comprehensive knowledge of FDA regulations, FDA QSR, ISO 13485:2016, Medical Device Directive Regulation (93/42EEC), and other national and international regulations
$77,200 – $123,700 USD salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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Title: Quality Inspector
Company: Data base Solution
Location: Fort Worth, TX
