Inspector I - Kronos in North Haven, CT at Apex Life Sciences

Date Posted: 2/11/2018

Job Snapshot

Job Description


Seeking Inspector with 2+ years of technical experience in quality role /manufacturing. Preferred experience includes Medical device materials testing, GD&T, functional & physical testing of components, ERP BPCS, Agile or similar system experience. For immediate consideration, please send your updated resume to nwalker@apexlifesciences.com

Shifts: To be trained on 1st shift for about 3 months until competency is confirmed (standard 1st shift hours 7 AM-3 PM) Then, the employee will be transferred to 2nd shift (standard 2nd shift hours 3 PM – 11 PM) 


POSITION DESCRIPTION: 
 

Perform the visual, dimensional, functional and physical testing of products / components in accordance with approved Inspection plan, Print, Master Inspection Characteristics and Departmental Standard Operating Procedures. Perform various duties under direction of Supervisor / Lead Technician in an environment that is continuously improving and changing. All job functions must be performed to ensure a safe and effective quality product to the customer. 

POSITION RESPONSIBILITIES: 

•    Set up inspection lot includes moving/handling shipment packages through the Inspection process. 
•    Perform visual, dimensional, functional and physical testing of components / products using various types of measuring instruments and equipment. 
•    Complete inspection on each item within the average standard time-frame. 
•    Ensure testing equipment is in proper operating condition and/or calibrated before use. 
•    Read and interpret complex prints and specifications as required. 
•    Review vendor/manufacturing traceability (where applicable), supplier documentation, warehouse documentation and the operational computer system for accuracy and completeness. 
•    Record inspection results and disposition lots in the operational computer system with accuracy and completeness. 
•    Review vendor data where applicable, to ensure product is acceptable within material specifications and supplier control plans. 
•    Scan certificate of compliance packet (Supplier, Warehouse, Incoming documentation) into the network folder and process through the Agile REC Workflow. 
•    Issue non-conformance reports and responds to customer regarding status of inspection lots. 
•    Support the return to vendor process (OLR/RTV) as needed. 
•    Support the record retention process as needed. 
•    Complete daily efficiency report in department database. 
•    Report all discrepancies to Senior Technicians and / or Supervisor. 
•    Perform departmental safety audits. 
•    Follow plant safety procedures and PPE requirements. 
•    Perform duties in accordance with current departmental operating procedures. 
•    Other duties as assigned with or without accommodation. 

SKILLS AND ABILITIES: 
 

•    Computer literacy including sound knowledge of software skills (Excel, Word, Power Point, etc.) 
•    Read and interpret engineering prints and specifications/Knowledge of GDT 
•    Proven track record of Organization skills. 
•    Requires ability to manage competing priorities. 
•    Demonstrated skills working independently with verbal / written instruction from Supervisor / Lead and uses time efficiently. 
•    Performance driven and seek to develop skills through additional training/educational programs.

Must be detailed oriented. 

QUALIFICATIONS AND EXPERIENCE: 
 

•    High school diploma 
•    Minimum of 2+ years technical experience working in a quality role or in a manufacturing operation environment. 
•    Knowledge of quality standards: ISO, GMP, and OSHA Rules and Medical Products Regulations preferred. 
•    Knowledge and experience with medical device materials testing. 
•    Demonstrated excellent listening, verbal, and written communication. 
•    Knowledge of production policies, processes, procedures, and equipment use in routine Incoming receiving material testing preferred. 
•    Knowledge of NCR/CAPA process. 
•    ERP BPCS or similar system experiences/knowledge. 
•    Agile or similar system experiences/knowledge. 

PHYSICAL JOB REQUIREMENTS: 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. 

•    Effective manual dexterity and eye hand coordination. 
•    Ability to view items using microscope for extended periods of time. 
•    Ability to stand / walk for extended periods of time. 
•    Medium Work: Up to 50 lbs (22kg) with frequent lifting and/or carrying of objects weighing up to 25 lbs (11kg). 
•    Ability to work daily overtime and Saturday. 
May require working directly in the clean room manufacturing floor.