Full-Time
Field Engineering Manager
Life Sciences
Confirmed live in the last 24 hours
SQA Services
201-500 employees
Quality management solutions for supply chains
Compensation Overview
$115k - $125kAnnually
Senior
El Segundo, CA, USA
Hybrid position requiring in-office presence.
- Thorough understanding of national and international laws, regulations and guidelines regarding GMP
- Experience in interacting with authorities (EU, FDA, etc.)
- Broad experience in Quality Management, including the development, establishment, and maintenance of quality systems (GXPs)
- Experience in GMP Lab operations (knowledge of analytical test method, analytical equipment uses, software systems, OOS process, etc.)
- Strong resolve and steadfastness in upholding quality standards at external partners as well as internally
- Strong leadership skills
- Ability and experience to work in a cross-functional team and an international environment.
- Experience in establishing Quality- and Technical Agreements
- Superior written and verbal communication, including technical writing.
- Bachelor’s or advanced degree in relevant scientific/engineering discipline.
- Demonstrated success with engineering project management and leadership.
- Supplier Quality Engineering experience, regarding:
- Deviation Management
- Change Control Management
- Equipment Qualifications
- Laboratory Controls
- Process Validations
- CAPA
- Risk Management Tools
- Batch Record Review Process
- Supplier Management
- Work with Clients to comprehensively understand and record requirements in a way that allows the development of adequate Program Scope with execution that maximizes sales and margin for the SQA business model.
- Kick off and monitor managed programs for Life Science clients for multiple grades of final products and raw materials.
- Identifying opportunities for the provision of additional services with existing clients.
- Conducting regular reviews with cross functional team to identify program trends and/or irregularities and bringing them (and subsequent recommendations) to the attention of the Client.
- Analyzing the activity of client programs and providing meaningful feedback and direction. This may include a recommendation for the reduction of one kind of activity in one area (e.g. on-site audits of low-risk suppliers), or recommendation for the increase of one kind of activity in another area (e.g. in-depth Assessments for a critical suppliers).
- Develop plans for associate monitoring, training, and development.
- Analyzing SQA’s internal Life Science accounts for opportunities for improvement and optimization.
- Maintain SQA to up to date regulatory requirements and update programs based on changes established.
- Performance of qualification/technical visits at vendor sites to support the appropriate vendor selection and supplier qualification.
SQA Services offers quality management solutions for complex supply chains, partnering with Fortune 500 companies across industries like aerospace, pharmaceuticals, and medical devices. The company operates globally, acting as an extension of its clients' quality teams to monitor and manage supply chain quality, which helps save time and costs. SQA uses a data-driven, risk-based approach to ensure that suppliers meet stringent quality standards, setting it apart from competitors. The goal is to enhance supply chain performance and compliance with regulatory requirements.
Company Stage
M&A
Total Funding
$282M
Headquarters
null, null
Founded
1995
Simplify's Take
What believers are saying
- Increased adoption of digital twins enhances SQA's data-driven quality management approach.
- AI-driven predictive analytics align with SQA's risk-based quality management strategy.
- Growing sustainability emphasis boosts demand for SQA's rigorous quality standards.
What critics are saying
- Emerging AI-driven platforms challenge SQA's market position with automated solutions.
- Complex global supply chains may lead to regulatory scrutiny for SQA's clients.
- Rapid technological advancements necessitate continuous innovation to maintain SQA's relevance.
What makes SQA Services unique
- SQA leverages a data-driven, risk-based approach to manage supply chain quality.
- The company acts as 'global eyes and ears' for Fortune 500 clients' quality needs.
- SQA's global presence allows effective management of supply chains in over 90 countries.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Retirement Plan
Paid Holidays
Paid Sick Leave