Job Details

Candidate will be responsible for assisting with the implementation of new projects in a manufacturing environment.  Duties may include creating and revising work instructions, developing and executing validations, analysis of failures to create corrective actions, pFMEA revisions, working closely with Senior Engineers to develop processes, training users in new processes, and equipment validations.  Candidate must have strong communication skills, critical thinking skills, able to work autonomously and a strong focus on time management.  Candidate must be able to work in multiple software systems including Microsoft Office, Agile PLM, SAP and others as needed.  Experience with Excel Macros is a plus.

Top 3 technical  skills that are required for the role:

1. 1-3 years of Medical Device industry experience, Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR), * Familiar with these standards: ISO 13485, ISO 14971, IEC 60601, Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.

2. Investigation and root cause analysis skills

3. Process Validation, Equipment Validation and Software/Spreadsheet validation knowledge

Education Required: Bachelors

Years’ Experience Required: 2-5yrs

Will the contractor be working 40 hours a week? If not, weekly estimate? 40hrs/wk;  1^st shift

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? On-site only

What is your timeline for scheduling interviews? Needs to be asap

What product line will this person support? As assigned

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.