The purpose for this position is to provide quality control for the manufacturing process and the ISO 13485 champion role in Portland.
The Product Quality Engineer works closely with marketing, product management, development, manufacturing, quality management, and regulatory within Clario business lines to establish/ensure compliance of Clario's products and assets with Clario's quality system and applicable regulations. The Product Quality Engineer is responsible for all tasks related to Technical Files/Documentation and for following established GMP/GCP/ISO compliant quality system practices.
Clario is a 50+ year old company that delivers industry-leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what's possible. From new trial modes to faster and integrated evidence and findings, our innovative clinical trial solutions mean we can unlock better evidence.
What we offer:
- Competitive compensation
- Medical, dental, and vision insurance beginning Day 1 of employment
- Flexible work schedules
- Attractive PTO plan
- Engaging employee programs
- Hybrid Role - The role will start out in the office with the ability to work hybrid in the future
What you'll be doing:
The Senior Product Quality Engineer works closely with marketing, product management, development, manufacturing, quality management, and regulatory within Clario business lines to establish/ensure compliance of Clario's products and assets with Clario's quality system and applicable regulations. The Senior Product Quality Engineer is responsible for all tasks related to Technical Files/Documentation and for following established GMP/GCP/ISO compliant quality system practices.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Ensure Product and Process compliance according to Medical Device and applicable non-Medical Device Regulations (e.g. FDA, EU MDR, HC MDR, RED, FCC) and ICH guidelines in regard to CAPA/Complaint Management, Production & Supply Chain, and Clinical Trial Services.
- Supports Design Assurance Engineer/Product Quality Engineer to ensure compliance and implementation of Clario's design control processes (e.g. PDLC, PLC, DLC, SDLC) in assigned projects.
- Reviews Development and Technical Documentation during Design Projects related to manufacturing; consideration of current standards and regulations for Transfer to Manufacture; implementing T2M to ensure that design and development outputs have been completed prior to becoming a final product.
- Participate in Risk Management throughout the medical device life cycle, incl. production and post-release.
- Contribution to the review of product and asset information, labeling, and/or marketing material.
- Supervision and direction of quality assurance activities in receiving inspection, production, process control, and final inspection, incl. decision upon quality-related measures before shipment of products and control execution of corrective measures.
- Organization and definition of all necessary inspections and testing techniques for the products in relationship with change management, complaint issues, final inspection, and production engineering.
- Perform quality checks on design control, production, and study-related documentation.
- Support Validation activities to ensure fulfills intended and 'indications for use' requirements.
- Support Clinical Trial Verification and Validation activities and resolve open issues.
- Support Usability activities to demonstrate fit for purpose and is supporting client needs. Support of the Regulatory Affairs designee, e.g. assist with international regulatory product registrations.
- Support the revision of procedures, policies, and work instructions to ensure compliance with local and international regulations. Decide on Deviations and Non-Conformity Activities.
- Compile change management, CAPA, and complaint-related KPIs including statistical analysis and periodic reports.
- Participate in the data analysis for post-market surveillance activities.
- Provide regulatory expertise to assigned projects throughout the life cycle. Perform and support any project-specific internal and external audit activities to ensure Compliance with Clario's QMS.
- Provide Training to departments on quality regulations and quality processes.
OTHER DUTIES AND RESPONSIBILITIES:
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 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.
Possibility to take on the role as Person Responsible for Regulatory Compliance (PRRC) and co-operate with Clario's other PRRCs in this role to ensure:
- Conformity of medical devices is checked in accordance with the QM system (before delivery).
- Technical documentation is kept up to date.
- Post-market surveillance obligations are fulfilled in accordance with Article 10(10) of MDR.
- Reporting obligations are fulfilled in accordance with the EU Directives.
QUALIFICATIONS AND SKILLS NEEDED:
Education:
- Technical Education (bachelor's degree or equivalent) required in computer sciences, Health/Life Sciences, or equivalent and relevant work experience in a product development environment.
Experience:
- At least 5 years of experience in Quality Management and/or Regulatory Affairs in a (EU) MDD/MDR (Medical Device) regulated environment (to act as PRRC).
- Preferred at least 5 years of experience with Design Controls (e.g. Computer System Validation), quality assurance activities (e.g. in receiving inspection, production, and process control and final inspection), and Quality Management systems (21 CFR Part 820, ISO 9001, ISO 13485) in a regulated environment.
- Experience as PRRC is a plus.
- Preferred working experience of ISO/cGMP and/or GCP related risk management activities and risk mitigation strategies.
- Basic auditor experience in a GCP/GMP environment is a plus.
- Good troubleshooting and communication skills.
- Good command of English. Additional language skills 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.
Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract.
The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.
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