Onsite position for a top Medical Device company in North Haven, CT. M-F, regular business hours.

TECHNICAL SKILLS

Must Have:

1. Experience in equipment IQ. 2. Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation. 3. Process Validation Lifecycle (from process characterization, operational qualification to performance qualification). 4. Preferred experience in DOE (with Minitab).

Other skills:

1. Computer and software validation

CSV. 2. SOP

Development. 3. Change control of Medical Devices.

Nice To Have:

1-3 years of Medical Device industry experience, familiar with

FDA 21 CFR

Part 820, EU 217/745 (EU MDR).

Familiar with these standards:

ISO 13485, ISO 14971, IEC

60601, Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS, and Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team.

JOB DESCRIPTION

This person will be responsible for validating and qualifying new packaging materials (foil, Tyvek, film) for absorbable suture products. They will be responsible for process development activities and creating the validation plans in compliance with company standards. They will be the project lead and communicate project deliverables and timing to engineering management. Top 3 technical skills that are required for the role: Packaging Experience Validation Experience - Process Development, OQ, IQ, PQ Familiarity with Cognex and Keyence based vision inspection systems

Education Required:

BS (or above) Engineering Degree;

Mechanical, Manufacturing, Packaging Years' Experience Required:

3-5 Required to be onsite full time. GST Focus Factory. Validating and qualifying new nylon film for our absorbable suture products.

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #

GRPC Pay:

$40.00 - $55.00 per hour Expected hours: 40.0 per week People with a criminal record are encouraged to apply

Work Location:

In person