Quality Engineer

VQ OrthoCare, Inc.; Vista (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

VQ OrthoCare, Inc. in Vista, California, seeks a Quality Engineer to apply quality engineering principles to support product and process quality through investigation, analysis, auditing and controlled change.

The role partners with Quality, Manufacturing and Product Development to sustain the Quality Management System, drive corrective actions and improve processes using ISO 13485 and FDA medical device requirements.

Qualifications

• Five to seven years of progressive Quality experience in a medical device or other regulated manufacturing environment.
• Working knowledge of ISO 13485, FDA medical device Quality System requirements, and Quality assurance and Quality engineering principles.
• Demonstrated experience with product and process investigations, root-cause analysis, corrective action and Quality improvement.
• Demonstrated experience independently performing internal QMS audits and evaluating objective evidence against established requirements.
• Experience analyzing Quality and manufacturing data and applying specifications, inspection requirements, acceptance criteria, sampling methods and other product quality controls.
• Experience with controlled change in a regulated Quality Management System and working cross-functionally with Manufacturing, Inspection, Engineering, Product Development and other operational functions.

Responsibilities

• The Quality Engineer independently performs assigned Quality activities and works collaboratively with Quality, Manufacturing, Product Development and other functional areas to support effective Quality System and product quality outcomes.
• Apply Quality System principles and requirements in accordance with Company procedures, ISO 13485 and applicable FDA medical device requirements.
• Serve as an internal QMS auditor, independently planning and performing assigned audits of Quality System processes and applicable business functions against ISO 13485, Company procedures and other applicable requirements; evaluate objective evidence, document findings and support appropriate follow-up.
• Develop and maintain extensive knowledge of Company products, components, specifications, manufacturing processes, inspection requirements and known failure modes to support effective Quality evaluation and decision-making.
• Investigate product defects and failures, including evaluation of returned product and relevant product, manufacturing, complaint and Quality history, to characterize failure modes, determine contributing factors and identify recurring or potentially systemic conditions.
• Collect, analyze and interpret product and Quality data to identify trends, variation, recurring conditions and potential quality signals and contribute to the development of meaningful data collection, analysis and reporting methods.
• Lead assigned corrective action, nonconformance, root-cause investigation and Quality improvement activities or participate as an active member of cross-functional teams responsible for evaluating and resolving Quality issues.
• Prepare and update controlled documents as assigned, including initiating change documentation, developing required revisions, obtaining appropriate technical and functional input, verifying proposed changes, evaluating impacts and related downstream activities and completing applicable requirements through the Company's self-service documentation process.
• Support maintenance of Device Master Record (DMR), technical file and other applicable product documentation by completing assigned updates, verifying current and applicable documentation and supporting alignment of affected records and repositories following approved changes.
• Work cross-functionally with Manufacturing, Inspection, Product Development and other applicable functions to address product and process quality issues and support implementation of appropriate corrective and improvement actions.
• Support development and revision of inspection plans, acceptance criteria, sampling methods and other product quality controls associated with product, process, specification and controlled-document changes.
• Provide backup support for Quality Inspection and other Quality workflows as needed, performing assigned activities in accordance with established procedures, specifications and acceptance requirements.
• Develop subject-matter expertise and assume responsibility for assigned Quality System areas as knowledge, proficiency and organizational needs evolve.

Skills

Quality engineering

Audits

Root-cause analysis

Data analysis

Cross-functional collaboration

Documentation

Job description

VQ OrthoCare provides noninvasive medical products focused on orthopedic bracing and electrotherapy. The Quality Engineer is responsible for applying quality engineering principles and analytical methods to support product and process quality through investigation, analysis, auditing, controlled change and cross-functional quality activities.

The position evaluates product and process issues, supports corrective action and continual improvement and develops subject-matter expertise in assigned areas of the Quality Management System.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The Quality Engineer independently performs assigned Quality activities and works collaboratively with Quality, Manufacturing, Product Development and other functional areas to support effective Quality System and product quality outcomes.

• Apply Quality System principles and requirements in accordance with Company procedures, ISO 13485 and applicable FDA medical device requirements.
• Serve as an internal QMS auditor, independently planning and performing assigned audits of Quality System processes and applicable business functions against ISO 13485, Company procedures and other applicable requirements; evaluate objective evidence, document findings and support appropriate follow-up.
• Develop and maintain extensive knowledge of Company products, components, specifications, manufacturing processes, inspection requirements and known failure modes to support effective Quality evaluation and decision-making.
• Investigate product defects and failures, including evaluation of returned product and relevant product, manufacturing, complaint and Quality history, to characterize failure modes, determine contributing factors and identify recurring or potentially systemic conditions.
• Collect, analyze and interpret product and Quality data to identify trends, variation, recurring conditions and potential quality signals and contribute to the development of meaningful data collection, analysis and reporting methods.
• Lead assigned corrective action, nonconformance, root-cause investigation and Quality improvement activities or participate as an active member of cross-functional teams responsible for evaluating and resolving Quality issues.
• Prepare and update controlled documents as assigned, including initiating change documentation, developing required revisions, obtaining appropriate technical and functional input, verifying proposed changes, evaluating impacts and related downstream activities and completing applicable requirements through the Company's self-service documentation process.
• Support maintenance of Device Master Record (DMR), technical file and other applicable product documentation by completing assigned updates, verifying current and applicable documentation and supporting alignment of affected records and repositories following approved changes.
• Work cross-functionally with Manufacturing, Inspection, Product Development and other applicable functions to address product and process quality issues and support implementation of appropriate corrective and improvement actions.
• Support development and revision of inspection plans, acceptance criteria, sampling methods and other product quality controls associated with product, process, specification and controlled-document changes.
• Provide backup support for Quality Inspection and other Quality workflows as needed, performing assigned activities in accordance with established procedures, specifications and acceptance requirements.
• Develop subject-matter expertise and assume responsibility for assigned Quality System areas as knowledge, proficiency and organizational needs evolve.

QUALIFICATIONS

• Five to seven years of progressive Quality experience in a medical device or other regulated manufacturing environment.
• Working knowledge of ISO 13485, FDA medical device Quality System requirements, and Quality assurance and Quality engineering principles.
• Demonstrated experience with product and process investigations, root-cause analysis, corrective action and Quality improvement.
• Demonstrated experience independently performing internal QMS audits and evaluating objective evidence against established requirements.
• Experience analyzing Quality and manufacturing data and applying specifications, inspection requirements, acceptance criteria, sampling methods and other product quality controls.
• Experience with controlled change in a regulated Quality Management System and working cross-functionally with Manufacturing, Inspection, Engineering, Product Development and other operational functions.

Preferred:

Experience with Class I and Class II medical devices.

CERTIFICATIONS

ISO 13485 Internal Auditor or Lead Auditor training/certification preferred. Evidence of completed auditor training should be provided.

ASQ certification or demonstrated professional development in Quality auditing, Quality engineering, Quality improvement or related Quality disciplines is preferred.

COMPETENCIES

• Ability to interpret and apply Quality System procedures, standards, specifications and applicable requirements.
• Strong analytical and investigative skills with the ability to evaluate evidence, identify patterns, determine broader Quality implications, and reach supportable conclusions.
• Working knowledge of root-cause analysis, corrective action, risk-based thinking and continual improvement principles.
• Ability to understand established processes and current-state requirements before recommending or implementing change.
• Ability to independently plan and execute assigned work, exercise sound professional judgment, and recognize when additional expertise or escalation is required.
• Strong cross-functional communication, collaboration, organization, documentation and follow-through.

SUPERVISORY RESPONSIBILITIES

This position does not have supervisory responsibilities.

PHYSICAL AND MENTAL DEMANDS

• Regularly required to sit, stand, walk, type, read, review records and use computer systems.
• Ability to work within office, manufacturing, warehouse and inspection environments.
• Ability to examine products and components and review specifications, processes, records, data and other technical information.
• Ability to manage multiple priorities, conduct investigations and exercise professional judgment within a regulated environment.

WORK ENVIRONMENT

Reasonable accommodations may be provided to allow qualified individuals with disabilities to perform the essential duties and responsibilities.

The work environment may include office, manufacturing, warehouse, inspection, supplier, customer and audit settings consistent with assigned Quality responsibilities.