Quality Engineer

This position will be a part of a Quality team responsible for ensuring that all activities and products meet quality and regulatory requirements. This includes planning, monitoring, and reporting on all quality activities throughout the product's medical device design, development, manufacturing, and life cycle. The Quality Engineer will work closely with various stakeholders, including R&D engineers, manufacturing engineers, regulatory affairs, project managers, regulatory bodies, suppliers, and marketing to identify and mitigate risks, identify opportunities for improvement, and ensure compliance with relevant standards and regulations

• Continually seeks to drive improvements in product and process quality.
• Drive the design & execution of Production Release Process project for components & finished devices.
• Lead and/or participate in company-wide Corrective and Preventive Actions projects.
• Provide Quality support to facilitate resolution of product nonconformities.
• Assists in product/process analysis and investigations related to customer complaints.
• Direct or assist training for processes / methodologies.
• Act as an effective leader/team member in supporting quality disciplines, decisions and practices.
• Provide sound problem-solving methodologies in identifying, prioritizing, communication and resolving quality issues.
• Develop incoming inspection processes and support incoming inspection activities.
• Provide in-process QA support to include inspection and document review.
• Manage validation planning process, including writing and executing equipment/process, protocols/reports.
• Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing. Lead complaint investigations on returned product. Manage corrective action and quality improvement activities.
• Manage aspects of internal quality system relating to receiving inspection, complaints, MRB, etc.
• Assist in the performance of quality system internal auditing. Support management review meetings.
• Establish, monitor and evaluate quality system metrics.
• Develop Quality inspection plans.
• Develop and validate, using statistical methodologies and quality inspection sampling plans for internally manufactured and vendor supplied products, processes and components.
• Provide leadership and technical support for Quality & Regulatory Compliance (QRC) and Manufacturing Operations staff on all aspects of the manufacturing process controls.
• Communicates current and applicable good manufacturing practices (GMP) (e.g.: ISO
  13485 / 21 CFR Part 820 / CMDR) to business partners.
• Executes functions needed to support change control activities and document management requirements.
• Collaborates with business partners and peers to define validation and change control activity requirements for individual projects.
• Development of equipment and process validations by participating in the design of feasibility studies that assess manufacturing capability / reliability.

Education:

Bachelor's Degree in Engineering Science or scientific field (Biomedical or Chemical Engineering is Preferred)

Communication skills:
Bilingual in English and Spanish. Position involves contacts with individuals inside and/or outside the Organization where the nature of the information provided usually follows an established pattern. Such communications require only normal courtesy. Proven ability to work well as part of a team & on own with minimum supervision.

Technical Proficiencies:
Organizational Skills, Presentation Skills, Project Management, Results Driven, Mathematical Skills, Technical Capacity, Thoroughness, Time Management. Working with knowledge of FDA and other regulatory authorities with experience supporting compliance.

Judgment and Decision Making:
Problem Solving/Analysis

Experience:

3-5 years of overall professional experience from regulated organizations (preferably- medical devices, biomedical or pharmaceutical)

While performing the duties of this job the employee is required to stand; walk; sit; use hands to handle; utilize tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. The employee must be able to lift or move up to 40 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust and focus.

The Quality Engineer will work in an office and on-site environment, with occasional travel required to other sites or supplier facilities. This role may require working outside of normal business hours to meet project deadlines or respond to urgent quality issues.