Senior Quality Engineer I - Software

STAAR Surgical; Monrovia (CA); On-site; USD 115,000 - 150,000; Full time

Job summary

STAAR Surgical is seeking a quality engineering professional to coordinate SaMD and software-related quality activities. You will oversee design control, risk analyses, verification/validation, and change management across SaMD and related software platforms.

The role involves guiding investigations into nonconformances, leading CAPA, and ensuring compliant release of software applications. Ideal candidates hold a Bachelor's in engineering/sciences, with CQE preferred, and have multiple years in

Qualifications

• Experience writing technical documents, including validation/compliance papers and protocols.
• Fluent written and spoken English required.
• Strong project management, organizational, writing, and presentation skills.
• Ability to communicate across diverse cross-functional teams and influence decisions.
• Strong written and oral communication skills.

Responsibilities

• Coordinate quality engineering activities across SaMD, Quality System software, and Manufacturing software.
• Provide technical expertise through the software lifecycle with focus on SaMD (design control, risk analyses, verification/validation).
• Develop cross-functional strategies for compliant SaMD releases and other software apps.
• Lead or contribute to design control, validation policies, and CAPA resolutions.

Skills

Technical writing

English proficiency

Project management

Communication

Presentation

Education

Bachelor's degree in engineering or sciences

Advanced degree preferred

CQE certification preferred

Job description

• Coordinate quality engineering activities supporting the Software as a Medical Device (SaMD), Quality System software, and Manufacturing software platforms to achieve business objectives.
• Provide technical expertise through the software lifecycle, with a focus on SaMD, in the following areas: design control, risk analyses, verification/validation strategy, maintenance and change management.
• Develop strategy as part of cross-functional teams to support the compliant and effective release of SaMD and other software applications.
• Provide guidance and leadership on development / review of design control and validation policies and procedures, and resolutions to quality engineering issues. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Provide technical expertise to the risk documentation process.
• Provide guidance and leadership on investigations involving software nonconformances, product or component failures, or customer complaints by leading or participating in the investigation process, technical troubleshooting, FMEA, hazard, or other risk analysis, determining root cause and recommending CAPA.
• Participate in the preparation of nonconformance investigations and responses, and completion of corrective action plans as needed.
• Provide guidance and leadership on design processes and site engineering functions to identify critical parameters and improve process quality.
• Participate on Design Control New Product development teams; advise the team on design control requirements; develop, review and approve design control deliverables related to quality engineering and validations.
• Other duties as assigned.

Main Job Responsibilities / Competencies

• Coordinate quality engineering activities supporting the Software as a Medical Device (SaMD), Quality System software, and Manufacturing software platforms to achieve business objectives.
• Provide technical expertise through the software lifecycle, with a focus on SaMD, in the following areas: design control, risk analyses, verification/validation strategy, maintenance and change management.
• Develop strategy as part of cross-functional teams to support the compliant and effective release of SaMD and other software applications.
• Provide guidance and leadership on development / review of design control and validation policies and procedures, and resolutions to quality engineering issues. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Provide technical expertise to the risk documentation process.
• Provide guidance and leadership on investigations involving software nonconformances, product or component failures, or customer complaints by leading or participating in the investigation process, technical troubleshooting, FMEA, hazard, or other risk analysis, determining root cause and recommending CAPA.
• Participate in the preparation of nonconformance investigations and responses, and completion of corrective action plans as needed.
• Provide guidance and leadership on design processes and site engineering functions to identify critical parameters and improve process quality.
• Participate on Design Control New Product development teams; advise the team on design control requirements; develop, review and approve design control deliverables related to quality engineering and validations.
• Other duties as assigned.

Requirements

EDUCATION & TRAINING

• Bachelor’s degree, preferably in Engineering or sciences.
• Advanced degree preferred.
• Certified Quality Engineer (CQE) or equivalent preferred

Experience

• Five years’ experience in validation and/or design control in the medical device software industry, including the practical application of FDA Quality System Regulation and ISO 13485; or equivalent combination of education/experience.
• Experience in medical device software change management required.
• Experience in vision care or intraocular lens industry preferred.
• General knowledge of medical device software requirements (IEC 62304, IEC 82304) required.
• Knowledge of international/ISO standards on ophthalmology preferred
• Applicant must be knowledgeable about regulatory/compliance/validation issues, be self-motivated, intelligent and reliable.

Skills

• Experience in writing technical documents, especially compliance and/or validation/quality assurance documents and protocols required.
• Proficiency in written and spoken English required.
• Excellent project management, organization, writing, communication and presentation skills required.
• Ability to communicate in a wide variety of communication styles and to influence and build consensus across cross-functional groups.
• Must have strong written and oral communication skills.

Pay range: $115K - $150K - Final compensation/salary will depend on experience.

STAAR Surgical is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.. #USA