Reference: Posted: Location: Hayward, CACompany: Planet Pharma GroupContact: ApplicationsEmail: PR Range: /hr DOEJOB DESCRIPTIONResponsibilities:Provide key support for management of nonconforming material (NC), RMA and deviations to ensure timely and efficient resolution of manufacturing interruptions and/or component quality issues
Develop subject matter expertise in SAP workflows for RMA and NCM handling
Executes usage decisions for RMA in line with QMS requirements
Verify accuracy and compliance of NC and deviation records
Plan and execute all aspects of material containment, including physical and system transactions and management of holds
Collaborate as part of cross-functional team to implement process improvements and/or resolve material or process issues
Support global project implementations (e.g. with system testing, local stakeholder communications, etc)
Ensures adequacy of nonconformance, deviation and CAPA records, investigations, and corrective actions
Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
Assist with material inspections as needed
Maintain company documentation related to assigned functions (e.g. work instructions, forms)
Promote “Zero Defect” mentality throughout the manufacturing process
Provide logistics support to external audits
Other activities as assigned
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.Requirements:0-3+ years’ experience in Quality Assurance supporting manufacturing in a regulated environment (equivalent manufacturing experience with demonstrated Quality mindset may substitute)
Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485) to actual situations
Practical experience with design controls, risk management, validation and/or change control desired
Experience with CAPA and failure investigation tools and techniques desired
Adaptable to fast-paced, dynamic work environment with shifting demands
Must have strong verbal and written communication skills, work well with diverse groups of people and be able to function independently of direct supervision
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.Education:
Bachelor’s degree, ideally in an engineering discipline
Develop subject matter expertise in SAP workflows for RMA and NCM handling
Executes usage decisions for RMA in line with QMS requirements
Verify accuracy and compliance of NC and deviation records
Plan and execute all aspects of material containment, including physical and system transactions and management of holds
Collaborate as part of cross-functional team to implement process improvements and/or resolve material or process issues
Support global project implementations (e.g. with system testing, local stakeholder communications, etc)
Ensures adequacy of nonconformance, deviation and CAPA records, investigations, and corrective actions
Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
Assist with material inspections as needed
Maintain company documentation related to assigned functions (e.g. work instructions, forms)
Promote “Zero Defect” mentality throughout the manufacturing process
Provide logistics support to external audits
Other activities as assigned
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.Requirements:0-3+ years’ experience in Quality Assurance supporting manufacturing in a regulated environment (equivalent manufacturing experience with demonstrated Quality mindset may substitute)
Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485) to actual situations
Practical experience with design controls, risk management, validation and/or change control desired
Experience with CAPA and failure investigation tools and techniques desired
Adaptable to fast-paced, dynamic work environment with shifting demands
Must have strong verbal and written communication skills, work well with diverse groups of people and be able to function independently of direct supervision
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.Education:
Bachelor’s degree, ideally in an engineering discipline
Mfg/Ops Quality Engineer 1 in hayward at Unknown Company
This position is listed as full time and onsite.