Mfg/Ops Quality Engineer 1

Planet Pharma; Hayward (CA); On-site; USD 99,573,000 - 124,645,000; Full time

Job summary

Planet Pharma in Hayward, CA is seeking a Quality Assurance professional to support management of nonconforming materials, RMA processes, and deviations within a regulated manufacturing environment.

You will develop SAP workflows for RMA/NCM handling and execute RMA usage decisions in line with QMS requirements, ensuring records are accurate and compliant. The role emphasizes risk-based decision making and cross-functional collaboration.

Qualifications

• Bachelor's degree in engineering preferred.
• 0–3+ years QA in a regulated manufacturing environment.
• Experience applying 21 CFR 820 and ISO 13485 to real situations.
• Familiar with CAPA, deviation handling and change control processes.

Responsibilities

• Provide QA support for nonconforming materials (NC), RMAs and deviations to ensure timely manufacturing continuity.
• Develop SAP workflows for RMA and NCM handling.
• Execute usage decisions for RMA per QMS requirements.
• Verify accuracy and compliance of NC and deviation records.
• Plan and execute material containment including holds and system transactions.
• Collaborate cross-functionally to implement process improvements.

Skills

Quality Assurance

CAPA & Investigations

Design Controls

Risk Management

Validation / Change Control

Communication Skills

Education

Bachelor's degree in Engineering

Tools

SAP

Job description

JOB DESCRIPTION

Target PR Range:34.75-43.50/hr DOE

Responsibilities:

• 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’ experiencein QualityAssurance supporting manufacturingin aregulatedenvironment (equivalent manufacturing experience with demonstrated Quality mindset may substitute)
• Experienceapplyingqualityregulationsand 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’sdegree, ideally in an engineering discipline