Position Title: Quality Engineer ll
Work Location: Marlborough, MA
Assignment Duration: 11 Months
Work Schedule: Monday - Friday ( 8-5)
Work Arrangement: Onsite

Position Summary:
This position provides support to the Global Supplier Quality organization dedicated to the oversight of components, other materials & services. He/she will provide technical knowledge across the organization to ensure suppliers can meet all requirements.

Key Responsibilities:

• Execute all applicable activities to comply with regulatory standards and meet the requirements established in the Quality Management System around supplier’s quality management.

• Conduct technical reviews of suppliers to understand their capability to make materials.

• Oversee, assess, and monitor suppliers making parts as it relates to manufacturing, process and quality control practices, corrective action, continuous improvement, and “First Article Inspection”.

• Define and approve PPAP (Production Part Approval Process) requirements for all new and revised purchased parts (as applicable). Follow up for their on-time completion.

• Work along with suppliers, to exceed the “fit, form and function” and reliability requirements, while working internally with Research & Development and Design Assurance.

• Issue and follow up on Agile Quality figures called “SCARs” and “SACAs” and “NCEs” related to suppliers. Monitor timing of the workflows to comply with key performance indicators established.

• Work collaboratively with suppliers on problem solving and root cause analysis to avoid repeat failures. Apply (as applicable), metrology and statistical measurement to problem analysis and resolution.

• Work with Post Market Surveillance and other applicable departments (Quality Engineering, MFG Engineering, Research and Development, R&D, etc.) to address complaints linked to supplier situations.

• Resolve quality day-to-day issues associated with suppliers around the globe by addressing non-conformities: call into containment and work along with the corresponding departments to achieve disposition of the impacted material (return to supplier, rework, sort, etc.). As applicable, collect and send back samples to suppliers if needed.

• As a resolve of a PPAP certified part number, work with Incoming Quality to include suppliers in the “Skip Lot Program” (as applicable) or remove suppliers out of it if poor quality is detected.

• Maintain complete supplier quality records as per the applicable procedure (e.g., supplier performance key indicators, supplier’s quality certifications, etc.). Update suppliers’ files when required and check that the information is accurate and complete, assuring that all applicable regulatory standards are met.

• Support audits as a subject matter expert. Travel might be required, domestic and international.

• Update the ERP system with the status of the approved suppliers for the different materials (as applicable).

• Attend functional and departmental meetings and follow up on action items accordingly.

• If needed, coordinate/ execute the change in specifications and/or procedures when required through the corresponding change order.

• Get trained in the respective procedures in the training system, before executing the respective task.

• Generate supplier performance metrics to be used in decision making. Provide the necessary reports to the stakeholders.

• As applicable, participate in periodic supplier review meetings, as well as follow up on the activities agreed upon in these meetings to ensure that they are carried out.

• Coordinate and execute activities related to the implementation of new suppliers as a result of the introduction of new products, transfer of products, alternate suppliers, etc.; ensuring that suppliers comply with the requirements stipulated in the quality system before the closure of the projects.

• Qualification of new suppliers and/or new parts/components of an already approved supplier.

• Perform other duties as required by his/her supervisor/manager.

Physical Demands:

• Sit; use hands to finger, handle or feel objects, tools, or controls.

• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.

• Exposure to moving mechanical parts, vibration and/or moderate noise levels.

• Safety Shoes with Impact and Compression Protection Must be worn in designated areas.

• Travel (please specify): Domestic and International.

Qualifications/ Skills:

• Communication—must be able to effectively communicate in both written and verbal forms, and at all levels in the organization.

• Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes.

• Ability to analyze a situation or data; evaluate relevant identifiable factors and translate this information into a meaningful proposal or action plan.

• High proficiency with Microsoft Office suite to produce reports, analyze data, etc. effectively.

• Working knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation (as applicable), cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001.

• Ability to handle and manage multiple complex projects.

• Must be able to work independently and with all levels of the organization.

• ISO 13485 leader auditor (Desirable).

• Quality System Regulation.

• Risk management.

• Validations (IQ, OQ, PQ) and root cause analysis (CAPA process).

• Knowledge of project management techniques.

• Measurement system analysis (GR&R, AAA). (Desirable)

• Statistical Process Controls (SPC) and statistical sampling know how.

• PPAP (Desirable).

• Must be able to follow applicable regulations (e.g. FDA, Canada, Brazil, Japan, etc.)

Education:

• Bachelor’s degree from a university in an Engineering field. Depending upon the expertise required by the business, the baseline engineering type might change. For example, if a molding subject matter expert (SME) is required, a Plastics Engineering degree might be pursued. On the other hand, if an SME is required in printed circuit boards or electronic components, an Electronic/Mechatronic Engineer degree might be required. ASQ Supplier Quality Engineer Certificate a plus.

Experience:

• Minimum 2 years of professional experience, with a Bachelor´s degree, in positions of a similar nature in the medical industry in the technical field, interacting with the quality management system.

• Full clean driver’s license (desirable).

Language:

• Proficiency written and oral in English. A second language is a plus.

Computer tools and knowledge required (Desirable):

• Microsoft Office

• Internet

• Email

• Project, Visio, Mini Tab

• Agile: Yes (desirable)

Must follow all applicable FDA regulations and ISO requirements.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.