Quality Management Office Specialist

Quality Management Office Specialist

Saama Technologies, LLC

Position Overview:

This position aims to provide quality management, control, assurance, and compliance with the development process of Saama products and services.

The Quality Management Office Specialist works closely with marketing, product management, development, and quality management within Saama business lines to establish and ensure that Saama’s products and services comply with Saama’s quality system and applicable regulations.

The Quality Management Office Specialist is responsible for all tasks related to Product Technical Files and Documentation and for following established GMP/GCP/ISO-compliant quality system practices. This position will also include tasks related to product and process improvement initiatives, from identification to project delivery via internal governance and control.

Key relationships:

●        Information Technology

●        Product Management

●        Research & Development

●        Quality management organization

●        Business Teams

●        Operations

 What We Value

●        Integrity: doing the right thing 

●        Solutions: solving core, complex business challenges

●        Collaboration: working as one team

●        Innovation: changing the game

●        Transparency: communicating openly

●        Enjoy & Celebrate: having fun

Key Responsibilities:

●        Ensures compliance with regulations (e.g., FDA, GDPR) and ICH guidelines regarding product and process development, implementation, and CAPA/Complaint Management.

●        Supports Design Assurance Engineer/Product Quality Engineer to ensure compliance and implementation of Saama’s design control processes in assigned projects.

●        Review development and technical documentation related to product development during the design phase; consider current standards and regulations to ensure that design and development outputs have been completed before becoming a final product.

●        Participates in Risk Management throughout the product life cycle, incl. production and post-release.

●        Contributes to review of product and service information and marketing material

●        Supervises and directs quality assurance activities in receiving inspection, production, and process control and final inspection, incl. decisions upon quality-related measures before the release of products and control execution of corrective measures.

●        Organizes and defines all necessary inspections and testing techniques for the products in relationship with change management, complaint issues, final inspection, and production engineering.

●        Performs quality checks on design control, production, and study-related documentation.

●        Supports Validation activities to ensure they fulfill intended use.

●        Supports Verification and Validation activities and resolves open issues.

●        Supports revision of procedures, policies, and work instructions to ensure compliance with local and international regulations. Decide on Deviations and Non-Conformity Activities.

●        Provide quality and compliance expertise to assigned projects throughout the life cycle.

●        Perform and support project-specific internal and external audit activities to ensure compliance with Saama’s QMS.

●        Provide Training to departments on quality and compliance processes.
 

Secondary Responsibilities

●        Provides assistance in all aspects of audits/audit conduct and QMS activities.

●        Ensure company efforts (e.g., Design Control, FMEA, Risk & Change Management) comply with regulations and external standards.

●        Tracks and/or trends audit issues and/or CAPAs until closure.

●        Provides root cause guidance to CAPA owners and/or conducts root cause analysis when assigned.

●        Champions timely management of quality event reports, audit findings, and CAPAs.

●        Follows up and verifies effectiveness checks.

●        Reports metrics to her/his manager and Saama management as required.

●        Ability to work with all Saama personnel and external personnel professionally and organizationally.

●        Identifies and implements process improvements, focusing on the audit program.

●        Provides assistance in all audit/inspection types (e.g., internal, external, vendor, regulatory inspections, etc.)

●        Support the tracking and trending of all compliance reports and audit activities.

●        Communicating effectively, verbally and in writing, with all internal and external clients

●        Escalating quality concerns and problems to the Quality Management Office Manager or designee(s)

●        Working directly with Saama development teams to ensure the accuracy and consistency of system development and validation deliverables.

●        Supporting/conducting/leading external (vendor/supplier) quality audits and hosts/leads Sponsor/customer audits

●        Facilitate quality training of peers on quality-related matters

Requirements

Education:

●        Technical Education (Bachelor's degree or equivalent) in computer sciences, health/life sciences, or equivalent is required, as is relevant work experience in a product development environment.

Experience:

●        Preferred at minimum 6 years of experience with Design Controls (e.g., Computer System Validation) and Quality Management systems (21 CFR Part 820, ISO 9001, ISO 13485) in a regulated environment.

●        Preferred at least 5 years working in cGMP and/or GCP-regulated environments.

●        Preferred working experience in ISO and/or GCP-related risk management activities and risk mitigation strategies

●        Basic auditor experience in a GCP/GMP environment is a plus.

●        Knowledge of and ability to apply GAMP5 and CSA guidelines

●        Good troubleshooting and communication skills

●        Good command of English. Additional language skills are preferred.

●        Experience managing CAPAs and complaints.

●        Excellent skills in analyzing issues and processes.

●        Team-oriented with excellent communication and organizational skills.

●        Strong interpersonal and communication skills, both verbal and written

●        Goal oriented

●        Detail oriented

●        Ability to make sound judgments

●        Superior problem-solving skills

●        Ability to manage multiple tasks effectively & efficiently

Work Environment

●        Remote

●        Travel less than 20% to an office environment

Physical Demands

●        This position requires frequent and repetitive use of a computer, keyboard, mouse, and hand and finger dexterity. 

Other Duties

Contributes to team effort by

●        Exploring new opportunities to add value to organization and departmental processes.

●        Support other departments in processing change requests, CAPA, and complaints.

●        Maintain the status of documents in design projects.

●        Support article introduction during development projects.

●        Communicate the status of Changes, CAPAs, and Complaints to other departments.

●        Adapt Quality Processes to changes in R&D and Production Processes if necessary.

●        Knowledge of all quality core processes

Maintains Professional and Technical Knowledge by

●        Attending and participating in applicable company-sponsored training

●        Attending educational workshops and reviewing professional publications

●        Benchmarking state-of-the-art practices

●        Participating in professional societies

●        Keeping informed of changes in the regulatory environment and/or regulatory requirements

●        Please note that this job description is not designed to cover or contain a comprehensive listing of the activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.

EEO 

●        Saama Technologies, LLC. provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state, or local laws.

●        This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.