Quality Engineer - Raleigh, United States - Merz North America

Description

The Quality Engineer, is responsible for providing support of R&D Quality activities as related to Medical Devices including the completion of day-to-day R&D Quality project activities.

Additionally, this position will operate as a liaison among the various R&D functions and the Quality Operations departments.
Essential Duties and Responsibilities

R&D Project Teams:
Responsible for supporting Medical Devices Project Teams and attending meeting in a Quality consultancy capacity
Support document reviews and regulatory submissions
Effectively manage project timelines as defined by department, project team, and corporate objectives

Facilitate and provide input to risk management activities throughout all stages of the device development process
Manage the risk management plan, risk file and risk report for assigned projects
Facilitate and provide input to human factors/usability activities throughout all stages of the device development process
Manage the human factors engineering/usability plan, Use/misuse error analysis, usability task analysis, facilitate formative and validation protocols and report

Design & Development:
Facilitate and provide input to Medical Device manufacturing and Design & Development activities throughout all stages of the device development process (e.g. general Product Development / Design Control customer input, specification development, verification and validation testing, manufacturing transfer, risk assessment, usability, design change control).
Provide input and review Design & Development documentation for assigned projects


Audits:
Conduct R&D related audits, both internal and external
Support R&D vendors/suppliers qualifications
Support all Merz regulatory authority inspections and certification body audits, as applicable


General R&D Support:
Support R&D related activities including but not limited to SOP creation and maintenance, NCRs, DCNs, CAPAs, deviations, change requests, archival, corporate, and departmental initiatives


R&D Quality Improvements:
Facilitate and support harmonization initiatives within the R&D group
Facilitate and support projects to improve R&D compliance and operational efficiencies


Quality Intelligence:
Stay informed of the latest updates related to applicable regulations to ensure R&D Quality policies and procedures remain compliant as related to Medical Devices
Provide updates to R&D staff, as applicable


Further Tasks:
Communicate effectively cross-functionally and raise questions/issues to the attention of executive management, as appropriate
Provide support to other R&D staff as needed and perform duties and assignments as required


Other duties as assigned:
Additional duties as needed to support the business and overall company objectives

Job Related Qualifications/Skills
Professional Experience

Required:
Minimum 2 years relevant Quality/Compliance and medical device development experience


Preferred:
Certification(s) – ASQ Certified Quality Manager; Certified Quality Engineer, or Certified Quality Auditor
Energy-Based Device Experience

Knowledge, Skills and Abilities

Required:
Proficient in all MS Office applications
Demonstrated organizational skills, ability to independently prioritize work and detail oriented
Strong verbal and written communication skills
Ability to effectively multitask and manage multiple projects
Experience with FDA, European agency regulations, cGMP regulations, and Quality Management software is highly preferred
Knowledge of regulatory requirements and standards for a medical device organization (i.e., 21CFR820, ISO 13485, ISO 14971, IEC 62304, ICH guidelines.)
Ability to work effectively in a global, matrix environment


Preferred:
Ability to travel up to 15%

Education

Required:
Bachelor's Degree in Engineering or Life/Health Sciences


Preferred:
Master's Degree

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

41 CFR c)

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