Revise and approve all documentation related to the areas of responsibilities such as: In Process Checker Charts, Product Retention Records, Control Charts, Mold Approvals, Batch Records related and others.
Responsible for routine manufacturing audits of machine parameter and/or set-ups for compliance as well as the product manufactured.
Perform routine audits of sampling techniques testing skills ¬¬¬¬and all documentation performed by the TIQ's.
Responsible for an immediate notification and awareness to Quality Management of potential Quality situations.
Assist and coordinate protocols.
Provide training as required on: Good Documentation Practices, SPC, Total Integrated Quality and others.
Provide support regarding mold approval and mold start up evaluations (if applied).
Gather, analyze, audit and interpret data using SPC methods so as to be able to predict trends and recommend process improvements that would impact favorably on product quality, scrap reduction, DPM reduction, Complaints reduction, price of non-conformance reduction and others. Maintains, revise and audits control chart and compute control chart limits as required.
Insure that all machinery, equipment, tools or any other measuring, monitoring material complies with Corporate, GMP and other regulatory requirements.
On a monthly basis publish Quality Indicators including DPM’s, Pareto Analysis on responsibility areas.
Submit improvements and/or modifications to specifications and Standard Operating Procedures.
Maintain good timely communication and awareness on DPM and complaints trends with the internal and external customers/suppliers. (if apply)
Assist in the development / certification of the TIQ’s.
Perform special projects related to responsibility areas.
Manually document (ex: checker chart) and/or electronically (ex: POMs) the required information to comply applicable procedures and specifications. This information includes but is not limited tp process parameters, lots, amount of production, and others.
Responsible for conducting EHS inspections to identify and correct safety hazards and environmental aspects. Follow the EHS applicable procedures, and analyze EHS incidents (including near misses) to find causes and take corrective action.
Observe data privacy policies at all time.
Provide support on Software application audits execution.
Assist on the generation and investigation of non-conformities
Requirements:
Bachelor Degree Science.
At least 0-2 years of experience dealing with related jobs on Medical Device Industry.
3rd Shift position. Availability to work ALL shifts, overtime, nights, weekends, and holidays as per business needs.
Knowledge in Data Entry – Microsoft Office Software.
Basic computer knowledge is required.
Experience in measurements instrumentation.
Good interpersonal skills.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed, as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers health benefits that include vision, dental, and pharmacy. Additional benefits offered to eligible employees include a 401K retirement plan with employer matching, a referral bonus program, and an EAP (Employee Assistance Program). SPECTRAFORCE provides unpaid leave as well as paid sick leave and vacation when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at benefits_pr@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $12.65/hr.
