Adecco Staffing is assisting a well-known Medical Device Manufacturing facility in Chelmsford MA with their needs for a Sr. Quality Engineer on 1st shift, 1 year contract.
Hours: 8am - 5pm, Monday-Friday
Pay: $55/HR
POSITION SUMMARY:
The Sr. Quality Engineer will primarily be responsible for supporting the qualification of new molds and tools for the Chelmsford, MA site. This will include working closely with the suppliers and any sub-suppliers on materials, specifications, development, first article inspections, and IQ, OQ, and PQ at Chelmsford. This role may also support Quality Assurance in Chelmsford with cross-functional quality assurance, quality management/compliance, quality control, and activities associated with all products and processes with a focus on manufacturing activities.
PRINCIPAL RESPONSIBILITIES:
· Be present, in person, at mold suppliers and their sub-suppliers as needed to support the development, first article runs, and validations/qualifications of new molds and tools.
· Be present, in person, in Chelmsford for production runs with first article samples as well as subsequent IQ, OQ, PQ validation activities.
· Be present, in person, for on-going production to ensure a successful transition to the new molds and tools as well as identify future opportunities for cost savings or increase in productivity.
· Support Incoming & In-Process Inspection teams with first article inspections and any non-conformances, SCARs, CAPAs, et cetera related to the molding vendor and their sub-suppliers.
· Support the Value stream with investigations required for field corrective actions including risk evaluation related to molds and tools.
· Perform internal audits and support supplier audits and supplier corrective actions.
· Quality & Cost Improvement Projects – lead and participate in key short-term projects on product or process improvements.
· Production & Process Controls – review, change and approve manufacturing procedures; test method validations; Quality Inspection plans and Process run sheets.
· Documentation Control – perform change controls (ADC/ECOs) as needed.
· Training – Perform QA training certifications on new production operators as needed.
· Support Engineering with new product development with quality planning, risk evaluation, and validation.
· Perform any additional QA tasks, as assigned by QA Manager or Plant Manager.
· Support Chelmsford Site Operating Playbook processes and KPI achievement.
EDUCATION / EXPERIENCE REQUIREMENTS:
· Minimum 4-year degree in an Engineering discipline – Mechanical, Biomedical, Plastics, Industrial, etc.
· ASQ Certified Quality Engineer or Certified Quality Auditor preferred.
· Minimum 5 years experience of Quality and/or related Manufacturing/Engineering experience in an ISO 13485 certified manufacturing site with the following skills and/or experiences:
o Qualification of new molds and/or tooling for a medical device component;
o Supplier Quality Engineering (i.e. Supplier Audits, Inspection Techniques);
o Non-conformance, SCAR, and CAPA;
o Design Controls for Medical Devices under FDA, EU MDR, etc.;
o Risk Management, DFMEA, PFMEA;
o Validations (product and process IQ/OQ/PQ);
o Problem-solving and quality improvement, including quantitative methods;
o Planning, controlling and assuring product and process quality related to molds and tools;
o Ability to work well with people at all levels of the organization, as well as external partners such as suppliers and regulatory agencies.
SPECIALIZED SKILLS & OTHER REQUIREMENTS:
· Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint, required.
· Working knowledge and/or experience with SAP and AGILE, strongly preferred.
· Good listening, verbal, and written communication skills.
· Excellent interpersonal skills with a demonstrated ability to work in a team environment.
· Ability to prioritize and adapt to shifting priorities.
· Ability to work independently with limited supervision.
TRAVEL REQUIRED: up to 50% local travel; Massachusetts & Vermont. Positions will be based in Chelmsford, MA site.
INTERESTED? If so, please apply directly to this posting!
Pay Details: $54.00 to $55.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
- San Francisco Fair Chance Ordinance