Interface with all departments in the organization in matters related to the quality system compliance.
Propose, lead, initiate and follow-up on Corrective Action and Preventive Actions (CAPA).
Support the Internal Audit program and provide backroom support for External Audits (Regulatory, Notified Body, and Customer).
Assist in the management of a Calibration and Preventative Maintenance program.
Disposition non-conforming material (NCMR).
Support product complaint investigations leading to root cause determination.
Support updates to the Risk Management File (FMEA, Hazard Analysis, Post Market Surveillance Reports, etc.).
Review and as needed update QMS procedures (SOPs, Work Instructions, Forms) to reflect latest industry standards, guidance documents and best practices.
Support the completion of validation protocols and test plans (IQ, OQ, PQ, test method and inspection method qualification).
As appropriate, assist in supplier qualification activities (initial assessments and categorization).
Other duties as assigned by manager.
Qualifications
Minimum 4-year degree in Engineering/Bio-Medical Engineering or Life Sciences (in lieu of degree additional work experience will be considered.)
7 to 10 years of experience as a Quality Engineer in the medical device industry; QMSR/ MDD/MDR and ISO-13485 experience required.
Must have experience in CAPA, NCMR, Internal/External Audits, calibration/preventive maintenance activities, risk management activities, and design controls.
Technical skills including the ability to read technical specifications and interpret industry standards and regulations.
Effective and professional communication skills; Internal (engineering, operations, R&D, etc.) and external (customers, auditors and suppliers) required.
Effective time/task management skills; excel working in a fast-paced environment.
Vaccination Notice
Additional Details
Does this worker qualify for overtime? : Yes
Scorecard Category : Engineering
Commercial Title : Sr. Quality Assurance Engineer
Vaccination Notice : This position requires Contingent Workers to be fully vaccinated against COVID-19 unless they are granted a medical or religious exemption.
Is this position for a pre-identified (PAYROLLED) candidate? : RECRUITED
If this is a pre-identified (PAYROLLED) candidate, please see note below and provide the following: : Name: Email Address: Phone Number: Pay Rate: Please also attach the pre-identified candidate's resume
Will this contingent worker require a computer or systems access or utilize a timeclock? : Yes
Time System : Fieldglass
Timeclock/Shift : Fieldglass|1
Enter Shift Start and End Time : 9 am-5 pm, but flexible for core hours (8 am-4 pm or 10 am to 6 pm)
Is there potential for this to convert to a full time position? : Yes
Non-Employee Class : Temporary Agency Worker
Will the worker be required to travel? : No
Is there potential for this assignment to be extended beyond 13 weeks? : No
Type of assignment : Full-time
Will this position require a DEA background check clearance? : No
Healthineers Vaccination Statement : Healthineers positions within applicable states require candidates to be fully vaccinated or obtain approval of special medical or religious exemption within three days of worker start date.Currently not applicable in the following states: Alabama, Florida, Iowa, Kansas, Montana, North Dakota, Tennessee, Texas, and Utah. States subject to change
APN Software services Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.”
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Medical Equipment Manufacturing
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