Senior Quality Engineer
Responsibilities Quality Engineering focuses on product compliance in support of Product Design and Manufacturing and including the critical quality system elements of CAPA and Complaint Investigations, Control of Nonconforming Product, Change Management, Risk Management, Process Validations/Test Method Validations, and Equipment Management. Works closely with Operations, Manufacturing Engineering, Design Engineering and Post-Market Surveillance groups to ensure a high level of product quality and effective and efficient corrective and preventive actions when needed. To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily. This position shall support Boston QA team by leading activities in the following areas as assigned:
CAPA investigations and action plan/VOE completion Nonconforming Product investigations Equipment Management activities Support for Process Validations/Test Method Validations Support for Changes to Design or Manufacturing Risk Management activities Complaint investigations Collection and reporting of metrics and data as required. QMS Remediation - workstream lead or team member Site Improvement Initiatives Development/Execution of Quality Plans External Audit support Daily operations activities for Site QA and/or Operations functions as assigned Qualifications BS degree in Engineering, Math or Science (Biology, Chemistry, Physics, Statistics, etc.) or 7-10 years of working experience in Quality Assurance/Control. Minimum of 5 years' experience in a regulated industry, preferably Medical Device Industry. Certified Quality Engineer, preferred. Working knowledge of QA Engineering related QMS elements including Design Controls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and Packaging Controls, Handling, Storage, Packaging and Distribution of Product). Strong Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation). Experience with CAPA processes (including central CAPA, Complaint Handling, Control of Nonconforming Product, OOT equipment analysis). Working knowledge in investigational techniques. Experience with Risk Management regulations and application (ISO14971). Working knowledge of medical device regulations (including FDA QSRs, ISO13485). Ability to communicate effectively (both written and oral) using English (or local language). Demonstrated ability to work cross-functionally in a team environment. Ability to work independently with little supervision. Proficient with the MS Office Suite. Some experience with Minitab and similar tools preferred. Must be able to observe company policies and safety procedures at all times.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
CAPA investigations and action plan/VOE completion Nonconforming Product investigations Equipment Management activities Support for Process Validations/Test Method Validations Support for Changes to Design or Manufacturing Risk Management activities Complaint investigations Collection and reporting of metrics and data as required. QMS Remediation - workstream lead or team member Site Improvement Initiatives Development/Execution of Quality Plans External Audit support Daily operations activities for Site QA and/or Operations functions as assigned Qualifications BS degree in Engineering, Math or Science (Biology, Chemistry, Physics, Statistics, etc.) or 7-10 years of working experience in Quality Assurance/Control. Minimum of 5 years' experience in a regulated industry, preferably Medical Device Industry. Certified Quality Engineer, preferred. Working knowledge of QA Engineering related QMS elements including Design Controls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and Packaging Controls, Handling, Storage, Packaging and Distribution of Product). Strong Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation). Experience with CAPA processes (including central CAPA, Complaint Handling, Control of Nonconforming Product, OOT equipment analysis). Working knowledge in investigational techniques. Experience with Risk Management regulations and application (ISO14971). Working knowledge of medical device regulations (including FDA QSRs, ISO13485). Ability to communicate effectively (both written and oral) using English (or local language). Demonstrated ability to work cross-functionally in a team environment. Ability to work independently with little supervision. Proficient with the MS Office Suite. Some experience with Minitab and similar tools preferred. Must be able to observe company policies and safety procedures at all times.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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