Quality Engineer - Acera Surgical Inc

Position Summary

The Quality Engineer is responsible for development, review, and continuous improvement of quality standards for operational processes and manufacturing outputs. This role is responsible for identifying issues, recommending solutions, creating and/or reviewing quality documentation, as well as ensuring compliance with regulatory requirements and quality standards for medical devices. This role may involve coordinating quality management/quality assurance activities, performing internal audits, and collaborating with cross-functional teams (both internal and external stakeholders) to maintain and improve Acera’s quality management system (QMS).

Responsibilities:

Quality Engineer Activities:

• Review, approve, and release various manufacturing batch records. This includes sorting, reviewing, staging, and working with external quality consultant for final approvals.
• Responsible for drafting necessary documentation for on-going manufacturing and post-processing activities such as cleanroom testing, device sterilization, routine testing, final testing reports, etc.
• Maintain calibration records and schedule equipment calibration as needed.
• Assist in preventive maintenance record control and reviews.
• Draft & execute test method validations as needed.
• Review and approve quality-related documents, including validation protocols, test reports, and change controls.
• Participate in risk management activities, including risk assessments and mitigation plans.
• Support the development and implementation of quality improvement initiatives.
• Other duties as assigned.

Quality Management System (QMS):

• Assist in maintenance and updates of the QMS in compliance with ISO 13485, FDA regulations, and other applicable standards.
• Ensure documentation control and records management in accordance with QMS requirements.
• Implement and monitor corrective and preventive actions (CAPA) to address non-conformities and improve processes.

Audits and Inspections:

• Assists in internal audits to assess compliance with QMS and regulatory requirements.
• Support external audits and inspections by regulatory authorities and customers.
• Follow up on audit finding and ensure timely closure of corrective actions.

Training and Education:

• Provide training on QMS processes, and quality standards to employees.
• Develop training materials and conduct training sessions for new hires and existing staff.

Collaboration and Communication:

• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality requirements are met.
• Communicate quality-related issues and performance metrics to management and stakeholders, as needed.
• Participate in quality meetings and provide input on quality-related matters.

Qualifications:

• Bachelor’s degree in engineering, life sciences, or a related field.
• At least 3-5 years of experience in quality engineering, quality assurance or quality management in the medical device industry.
• Knowledge of ISO 13485, FDA regulations, and other relevant standards.
• Experience with internal and external audits.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Detail-oriented with strong organizational skills.
• Ability to work independently and as part of a team.

Preferred Qualifications:

• Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) certification.
• Experience with risk management and CAPA processes.
• Familiarity with software validation and electronic QMS systems.
• Knowledge of statistical analysis, and familiarity with Six sigma principles.

Working Conditions:

• This position may require occasional travel to support audits and inspections.
• Work is performed in an office and manufacturing environment.

ABOUT ACERA SURGICAL 

Born from research and bold patient-focused innovation, Acera Surgical, Inc. is a growing bioscience device company commercializing a portfolio of synthetic hybrid-scale fiber scaffolds for regenerative medical applications. Acera Surgical is an Equal Opportunity/Affirmative Action Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. The company offers competitive benefits, including medical, dental and vision insurance, paid time off, 401(k), basic and supplemental life and AD&D, employee assistance program and more. Learn more at https://acera-surgical.com/.