Location: Wallingford CT
Duration: 6 Months+
Develop and oversee equipment qualification and process validation plans and lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations.
Assure quality systems of OEMs, manufacturers and suppliers are maintained and acceptance criteria are in alignment with component/product use and customer expectations.
Provide Quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes.
Provide QE support for Engineering changes by reviewing Change Requests for compliance, completeness and accuracy
Develop inspection criteria for components and finished devices
Investigate incoming inspection issues
Assist in the review and investigation of line failures
Support the sustaining activities
Provide product data analysis for CAPA investigation
Investigate and resolve CAPA issues as needed
Performs other duties as needed to ensure compliance with relevant FDA QSRs and ISO regulations.
Excellent technical writing, communication, and organization skills and working within FDA or similarly regulated environment, required.
Plans and manages assignments of significant technical scope
Perform technical and non-technical product failure evaluations documenting and effectively communicating root cause findings.
Skilled at performing reviews, system/product failure analysis, First Article Inspections (FAI), and Incoming Inspections, as required.
Skilled in creating, interpreting and modifying component/schematic drawings.
Support new product development and product engineering by generating and/or processing key documents which may include quality plans, design review, risk and hazard analysis, verification and validation plans, product and process validation.
Willingness to work as part of a team and strong verbal and written communication skills are essential.
Able to work independently and complete multiple assignments on time.
Skilled with applying Quality Tools.
Skilled in Internal Auditing and Lead Auditor duties.
Capable of making technical calculations involving the use of engineering and mathematical formulas such as finding standard deviations.
Skilled at trouble shooting and problem solving.
Skilled at interacting directly with suppliers, operation/manufacturing services and engineering support services.
Understanding Software Validation is preferred.
Skilled with Word or other word processing software, and SAP (or related) navigation, required. Experiences with multiple statistical/QS software packages are a plus.
Write routine procedures and reports and make necessary corrections.
Write and update Quality Inspection Plans.
I look forward to hearing from you
APN Software Services, Inc .
39899 Balentine Drive, Suite 385, Newark, CA 94560 .
| Fax: 510.623.5055 | Email: firstname.lastname@example.org