Quality Assurance Engineer/Product Development

Job Description

At Medica, we are seeking a Quality Assurance Engineer reporting to the director of Quality Assurance to work closely with Product Development, Technical Service, Manufacturing, Regulatory, Operations, and Quality.  The QA Engineer will be responsible for: (1) quality assurance (QA) activities and documentation associated with new development and design changes to ensure compliance with the quality system and (2) participating as a stakeholder in the design process to ensure product specifications and development activities are aligned with the organizations quality objectives.

This individual will provide oversight and generate quality documentation to ensure meet QMS compliance.  As part of a project team, the Quality Engineer will be responsible for Quality assurance input to and review of design specifications, Supplier Qualification, Manufacturing Quality Plan, Risk Management activities, design verification and validation review, and audit Design History Files for compliance,

Responsibilities:

• Represent Quality on product development teams as responsible individual for ensuring compliance with company quality and applicable regulatory requirements and standards.
• Lead effort and ensure completion of Risk Management activities for new and/or modified products and processes authoring risk management plans and reports, facilitating risk assessment activities.
• Work with Program Management to integrate quality by design concepts into the design and development policies and procedures.
• Work with Operations and R&D to develop manufacturing quality plans and set quality standards for new and/or modified products and processes to ensure a high level of product quality.
• Develop and implement traceability programs for new products and modified products
• Monitor compliance to design control processes and procedures
• Review and provide input for design verification and validation protocols and reports to ensure compliance with the quality management system.
• Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
• Lead master validation planning sessions for projects of all levels of complexity.
• Participate in supplier selection process and implement appropriate supplier quality controls during the development process
• Provide post release input from the quality system (non-conforming material reports, yield, rework) or external sources (customer complaints), for post release design and development activities.

Qualifications:

• Bachelor’s degree in science or engineering
• 3-7 years Quality Assurance and/or design and development experience.
• Ability to generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures.
• Experienced in writing Validation and Verification Protocols and Reports.
• Organizational skills as well as time management skills essential for project work.
• Self-motivated and able to balance multiple priorities and tight deadlines with minimal supervision.
• Prefer certification as a CQA, CQE, or CQM, and member of the ASQ.
• Prefer Six Sigma certification.
• Experience using quality tools and statistical programs (e.g. risk assessment (FMEA), experimental design (DOE) and statistical process control (SPC) is required.
• Strong written, mathematical. collaboration, communication skills
• Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards.

Interested Applicants should forward resume to:

Mary Williams
Human Resources Manager
Medica Corporation
[email protected]