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OrthAlign, Inc. · 2 months ago

Verification & Validation Sustaining Engineer II

Irvine, California, United States

Full-time

Onsite

Entry, Mid Level

2+ years exp

OrthAlign, Inc. is a growing medical device company looking for a Sustaining Quality Engineer II to provide expertise in sustaining engineering for their Class II medical device product lines. This role focuses on ensuring the manufacture of high-quality medical devices by collaborating with various teams to maintain compliance with quality requirements and facilitate continuous improvement activities.

BiotechnologyHealth CareHealth DiagnosticsMedicalMedical DeviceNavigation

No H1B

Responsibilities

Plan and execute quality-related maintenance and improvement activities related to devices as well as qualification of in-house materials to prevent or minimize quality issues

Develop and improve manufactured supplied parts inspection strategies based on establishment, implementation and improvement of related quality metrics and monitoring of critical to quality indicators

Collaborate with the Operations Engineers to determine the qualification and requalification activities for equipment qualification and process validation, process capability, test method validation and ISO 14971 risk management activities and process improvements

Lead CAPA and NCMR investigations and support investigation teams relating to product functionality and design improvement

Communicate effectively with internal counterparts regarding product related CAPA and other quality issues

Evaluate impact of proposed component, product and process change requests; lead cross-functional teams to identify and execute appropriate actions

Facilitate compliant and timely process deviation, change control and quality planning activities

Identify, propose and drive opportunities for improvement, including review and revision of procedures and associated documents. Support other quality system activities as directed by management

Qualification

ISO 13485ISO 1497121 CFR Part 820Root Cause AnalysisASQ Certified Quality EngineerStatistical techniquesMedical device manufacturingInterpersonal skillsWritten communicationVerbal communicationTeam collaborationAttention to detailOrganizational skills

Required

Your BA/BS Engineering-oriented degree and 2+ years of experience in medical device manufacturing

Understanding of and ability to interpret and apply ISO 13485, ISO 14971, and 21 CFR Part 820, specifically design controls, purchasing controls, risk management and production and process controls

Working knowledge of statistical techniques

Ability to read and interpret drawings

Experience with contract manufacturing and process validations

Proficiency leading and conducting Root Cause Analysis

Strong interpersonal relationship skills including negotiating and relationship management

Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint)

Excellent written and verbal communication skills

Ability to work as a collaborative team member as well as independently

Excellent attention to detail, producing high quality output

Results-oriented with appropriate urgency and tenacious follow-up

Flexibility and strong organizational skills with ability to prioritize multiple tasks

Sound judgment when making decisions and communicating with internal and external customers

Preferred

ASQ Certified Quality Engineer

Benefits

Competitive compensation including bonus and equity

Full benefits package including 401(k) and voluntary benefit offerings

Opportunities for career advancement

An evolving, engaging culture and workplace

Company

OrthAlign, Inc.

Our Mission: Driven by the belief that everyone deserves exceptional healthcare, we are committed to making empowering technologies accessible to all.

Founded in 2009

Aliso Viejo, California, USA

51-200 employees