Medical Device Sr. Quality Assurance Engineer at APN Software Services, Inc.

Job title: Sr. Quality Assurance Engineer

Location: Newton, MA 02466

Duration: Position terminating at the end of September (9/30/24). This role would have the option to convert to full time with the right candidate.

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)

100% onsite position
SAP and all MS Office Suite required
7 to 10 years of experience as a Quality Engineer in the medical device industry, with knowledge of QMSR, MDD, MDR, and ISO-13485
Effective communication, time/task management, and collaboration are essential for success
A minimum 4-year degree in Engineering/Bio-Medical Engineering or Life Sciences is strongly preferred. If no degree, some college is required with 10+ years of field experience required.
Immediate interviews as this position needs to be filled quickly.

Description:

Primary Responsibilities:

• 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.
• Notified Body/Regulatory Audit experience; Certified Quality Auditor (CQA) certificate is preferred.
• 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.