28 days old

Quality Specialist

Kelly Services
Lakeland, FL 33806


Hours: Monday - Friday from 8:00 a.m. - 4:30 p.m.

Starting Pay Rate: $24.00/hr.

The Quality Specialist is responsible for key activities in the Quality department e.g. supplier management, management & co-ordination of validation activities (software/equipment/process/product) with Customers, internal departments, external contractors & vendors/suppliers. Prefer applicants that have experience working in a "clean room" environment.

**Duties & Responsibilities**

+ Compliance

+ Maintain on-going understanding and knowledge of the latest regulatory requirements for in compliance with EU/U.S. regulations and guidance documents. Provide related updates to department management according to the latest EU/US and ICH requirements.

+ Conduct all activities in compliance with global and local procedures and EHS requirements.

+ Supplier Management

+ Supplier audits and assessments

+ Supplier qualification and approval

+ Providing Validation expertise to all areas of the facility, including;

+ Co-ordination and execution of equipment, processes, cleaning validations.

+ Review, preparation, approval and implementation of qualification protocols, deviations and change controls.

+ Provide input at key project phases e.g. concept/design through to the commissioning and qualification execution phases of a project.

+ Review validation documentation from contract vendors/suppliers to ensure that company requirements are met.

+ Co-ordinate/conduct training in Validation methodologies and related procedures, as required.

+ Present validation systems at internal and external audits in support of the QMS.

+ Environmental monitoring.

+ Co-ordination and review of Environmental monitoring.

+ Liaise within a project to ensure the correct completion of cleaning, biocompatibility etc.

+ Support the business for key operational activities e.g. non-conformances, work order review, specification approval, documentation control and auditing (where necessary).

**Scope of Power**

1. Has a right to:

2. Taking independent decision regarding releasing/certification or rejection of medical devices production batches or based on established procedures, obtained testing results, BHR and own experience.

3. Taking independent decision regarding releasing/certification or rejection of raw materials and packaging materials for medical devices manufacturing process.

4. Taking independent decision regarding obtained testing results for medical devices. The decisions in this matter are fully independent from the opinion of direct supervisor, the Board of Directors or other person who could influence its decision.

5. Has the right to stop production of nonconforming or medical devices.

6. Access to full information and documentation related to the packaging of and the manufacture of medical devices.

7. Access to all areas connected with the process of the manufacturing of medical devices

**Qualifications, Education & Skills Required**

+ Degree in Engineering/Science or **_equivalent work experience._**

**Work Environment**

+ Work is performed in a temperature controlled Clean Room.

+ Dress requirement per Gowning Procedure/Good Manufacturing Practice (QAD03-05).

+ Walking / Standing consistently for 8 to 10-hour shifts.

+ Approx. 40-60% travel

You can also email your resume directly to me at:

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2021-04-09 Expires: 2021-05-10

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Quality Specialist

Kelly Services
Lakeland, FL 33806

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