Position Title: Quality Engineer
Effective Date: 4/1/2024
Reports To: Director of Quality Management Systems
Position status: Exempt Full-Time
Primary Functions:
The Quality Engineer is responsible for assisting in designing and implementing an effective quality management system compliant with 21 CFR 820, ISO 13485, ISO 14971 as well as CAP/CLIA/NY State requirements and specific vendor specifications, as applicable. This includes collaborating with project teams to enable these teams to establish specifications as well as other documents required by 21 CFR 820, ISO 13485, ISO 14971, and applicable internal procedures in addition to guiding effective implementation in the production environment.
In addition, the Quality Engineer will assist with the implementation of compliant incident management, risk management (FMEAs), qualifications processes (software, equipment, vendors, materials), design review, and change control processes as well as assist with conducting internal audits and supporting external audits (e.g., FDA (Food and Drug Administration)).
The Quality Engineer will collaborate closely with the Quality Assurance (QA) and Quality Management Systems (QMS) team members to optimize and facilitate the implementation of business processes that enable efficient harmonization and parallelization of both FDA compliant workstreams in addition to existing CLIA/CAP operations as well as new product development.
The Quality Engineer will report directly to and work closely with the Director of Quality Management Systems and the VP of Regulatory Affairs.
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Essential Duties and Responsibilities:

• Responsible for assisting implementation of an effective quality management system
• Provides design quality assurance guidance to product development teams and assists in reviewing and approving development documents. Assists in the creation of design control deliverables (planning documents, user needs, design inputs, risk management, design output specification, design verification and validation activities, and design transfer.)
• Responsible for reviewing design changes and for providing constructive feedback in a timely manner.
• Stay current with industry trends, regulatory changes, and best practices in QMS
• Drive continuous improvement to enhance QMS
• Assess nonconformities or other quality issues during manufacturing/assembly
• Assess and qualify suppliers in a timely manner.
• Assist with quality control processes and procedures to ensure consistency and reliability in manufacturing/assembly.
• Establish and monitor quality system metrics for an ongoing assessment of the QMS.
• Identify opportunities for process improvement within the quality management system.
• Collaborate with cross-functional teams to implement quality initiatives to enhance efficiency and effectiveness.

• Ensure risk management processes are integrated into product development and manufacturing processes. This included appropriate verification and validation activities (as necessary) prior to implementation.

• Responsible for maintaining and improving the risk management system throughout product lifecycle.
• Supports preparation of quality plans and other documents.
• Performs other duties as assigned.

Skills, Knowledge, Abilities:
Mental Abilities and Skills Requirements-

• Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems. Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
• Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
• Adjusting actions in relation to others' actions.
• Effectively work with members of cross-functional teams.
• Ability to influence peers.

Knowledge Needed-

• Substantial knowledge and experience with application of ISO 13485, 21 CFR 820 (in particular 21 CFR 820.30) and ISO 14971 requirements, as well as of applicable FDA performance standards for HIV (Human Immunodeficiency Virus), HCV and STI (Sexually Transmitted Infections) tests.
• Working knowledge of CLSI (Clinical and Laboratory Standards Institute) standards and other appliable standards
• Clear understanding of statistical techniques for design and manufacturing of medical devices
• Provide guidance and support to personnel on quality-related issues and best practices

Education and Certification:
Education/Experience Requirements-

• A Bachelor’s degree in Engineering, Physics, Biology, Chemistry, or equivalent scientific discipline required.
• At least 5 years of working experience in Design Quality Assurance role(s) in the medical device or diagnostic industry.

Physical Requirements:

• Must be able to sit or stand for up to 8 hours per day.
• Occasionally required to lift up to 20 lbs.
• Regularly required to sit, stand, bend, reach, and move about facilities.

Work Environment:

• Vancouver Office – Work will be performed in the office. This is not a remote position. Workweeks usually consist of 40 hours.

Office Environment:

• Several common areas and meeting rooms for collaboration.
• Large windows which let in natural light during working hours.
• Fully equipped break room and bathrooms.

Lab Environment:

• Noise levels vary based on the flow of business.
• Most floors are tile or concrete - individuals may stand for extended periods of time on these surfaces.

Tools and Technology:

• Laptop and necessary accessories

Hazards:

• Work is performed in an office environment, full manual dexterity and visual acuity required. However, access to the laboratory may be necessary and therefore employee may be exposed to potential physical harm from hazardous chemicals, infectious diseases, bloodborne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools, and equipment.
• Hepatitis B Vaccination provided at no cost to employee.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by associates assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Molecular Testing Labs embrace diversity and is an Equal Opportunity Employer, and hire without regard to any individual's race, age, color, national origin, ancestry, disability, veteran status, religion, marital status or domestic partnership; pregnancy, childbirth or related medical conditions; other medical conditions or genetic characteristic; sexual orientation, gender, gender identity or transgender status; or any other basis protected by state, federal, or local law, regulation or ordinance. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Molecular Testing Labs provides reasonable accommodation upon job seeker request in all steps of the employment process.

Job Type: Full-time

Pay: $75,000.00 - $120,000.00 per year