Milwaukee, WI, United States
$70,000 - $80,000
10 months ago
An exciting new opportunity has become available as a Quality Engineer within a successful orthopaedic company at their manufacturing site in Wisconsin.
The Quality Assurance Engineer performs specialized level work assignments and/or oversees and implements CAPAs, handles complaints, and manages the company’s Quality Management System to ensure the global products and procedures comply with regulatory agency specifications.
The candidate will:
- Be responsible for carrying out technical investigations for upcoming and existing marketable products.
- Handles the Post Market Evaluation (PME) for vendor and customer complaints, as well as CERs.
- Take ownership of the Quality Management System under ISO13485:2016 global standards, ensuring an audit ready standard at all times.
- Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA and other worldwide regulatory agencies to various international affiliates.
- Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
- Bachelor’s or Masters in Biomedical Engineering is preferred, or similar.
- Experience in the Medical Device Industry (Orthopedics preferred).
- Minimum 3 years Quality experience.
- Experience with EU and other international medical device regulations and submissions.
- Experience with ISO 13485:2016 and MDSAP implementation preferred.
- Ability to work in a fast-paced startup business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Experience working in a broader enterprise/cross-division business unit model.