B
QA Engineer
Accepting applicationsbioMérieux · Philadelphia, PA
Full-Time Associate aiateganrfsic
Posted
6d ago
Category
Test
Experience
Associate
Country
United States
Description
Position Summary
The QA Engineer is responsible for supporting the full Quality Management System (ISO 9001 based) at the Philadelphia site under the guidance of the Quality Associate Manager.
Position Duties
Responsible for executing the Quality function for verifying and maintaining records as directed for non-conformances, deviations, root-cause-investigations, change controls, CAPAs complaints as defined within local procedures.
Maintenance of quality system records including preparation, verification and filing of Quality documentation to ensure that it meets applicable customer, regulatory, and corporate requirements
Assist employees in obtaining identification numbering for internal and external documents, and controlled documentation.
Assist with continuous improvement programs/projects to improved compliance to regulatory and industry standards.
Assist in employee training and maintain employee training records under the QMS.
Complete data entry in quality databases for new and modified documents.
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.
Qualifications
Required Education, Training and Experience
Bachelor's degree required Life Sciences, Engineering, Quality, or related field required
Education Substitution: In lieu of a Bachelor's degree, 4 years of additional relevant experience, defined below, will be accepted.
2+ years of professional related experience with degree in ISO related industry experience required such as quality, manufacturing or other regulated environments
or 6+ years of professional related experience in lieu of degree in ISO related industry experience required such as quality, manufacturing or other regulated environments
Preferred Education, Training And Experience
Prior experience executing and building a Quality Management Systems procedures and document control is preferred.
Familiarity/knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO9001, ISO13485, ISO17025) is a plus.
Experience managing nonconformances, investigation writing experience and change control preferred
Demonstrated experience in manufacturing operations is preferred
Knowledge, Skills, And Abilities (KSA’s)
Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently
Flexibility, being highly adaptable and resilient to thrive in a dynamic work environment.
Driving continuous improvement by evaluating processes and implementing necessary changes
Influence change using skills and relationships to persuade others to adopt new ideas, behaviors, or processes.
Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance
Competence in the use of Quality Tools and Techniques and knowledge of quality systems (SAP/LIMS/Trackwise) is a plus.
Supervisory Responsibilities
Operational or tactical decisions impacting daily team performance with little-to-no supervisory review
Strategic decisions impacting future direction and alignment with organizational mission with supervisory review/approval required
Supplemental Data
Includes financial indicators such as site revenue, number and complexity of products, and number of product launches per year
Includes KPIs such as conformity with quality standards and procedures, document revision turnaround times, and customer complaints
Includes key internal and external contacts such as Quality leadership, R&D and Operations leaders, QC department, General Managers, Site/Subsidiary Managers, and functional leaders
Working Conditions And Physical Requirements
Ability to remain in stationary position, either sitting or standing, for prolonged periods
Ability to ascend/descend stairs, ladders, ramps, and the like
Travel Requirements
Domestic travel required: 5%
The estimated salary range for this role is between $67,000 and $105,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMérieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.
In addition, bioMérieux offers a competitive Total Rewards package that may include:
A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].
BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
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Position Summary
The QA Engineer is responsible for supporting the full Quality Management System (ISO 9001 based) at the Philadelphia site under the guidance of the Quality Associate Manager.
Position Duties
Responsible for executing the Quality function for verifying and maintaining records as directed for non-conformances, deviations, root-cause-investigations, change controls, CAPAs complaints as defined within local procedures.
Maintenance of quality system records including preparation, verification and filing of Quality documentation to ensure that it meets applicable customer, regulatory, and corporate requirements
Assist employees in obtaining identification numbering for internal and external documents, and controlled documentation.
Assist with continuous improvement programs/projects to improved compliance to regulatory and industry standards.
Assist in employee training and maintain employee training records under the QMS.
Complete data entry in quality databases for new and modified documents.
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.
Qualifications
Required Education, Training and Experience
Bachelor's degree required Life Sciences, Engineering, Quality, or related field required
Education Substitution: In lieu of a Bachelor's degree, 4 years of additional relevant experience, defined below, will be accepted.
2+ years of professional related experience with degree in ISO related industry experience required such as quality, manufacturing or other regulated environments
or 6+ years of professional related experience in lieu of degree in ISO related industry experience required such as quality, manufacturing or other regulated environments
Preferred Education, Training And Experience
Prior experience executing and building a Quality Management Systems procedures and document control is preferred.
Familiarity/knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO9001, ISO13485, ISO17025) is a plus.
Experience managing nonconformances, investigation writing experience and change control preferred
Demonstrated experience in manufacturing operations is preferred
Knowledge, Skills, And Abilities (KSA’s)
Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives
Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently
Flexibility, being highly adaptable and resilient to thrive in a dynamic work environment.
Driving continuous improvement by evaluating processes and implementing necessary changes
Influence change using skills and relationships to persuade others to adopt new ideas, behaviors, or processes.
Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance
Competence in the use of Quality Tools and Techniques and knowledge of quality systems (SAP/LIMS/Trackwise) is a plus.
Supervisory Responsibilities
Operational or tactical decisions impacting daily team performance with little-to-no supervisory review
Strategic decisions impacting future direction and alignment with organizational mission with supervisory review/approval required
Supplemental Data
Includes financial indicators such as site revenue, number and complexity of products, and number of product launches per year
Includes KPIs such as conformity with quality standards and procedures, document revision turnaround times, and customer complaints
Includes key internal and external contacts such as Quality leadership, R&D and Operations leaders, QC department, General Managers, Site/Subsidiary Managers, and functional leaders
Working Conditions And Physical Requirements
Ability to remain in stationary position, either sitting or standing, for prolonged periods
Ability to ascend/descend stairs, ladders, ramps, and the like
Travel Requirements
Domestic travel required: 5%
The estimated salary range for this role is between $67,000 and $105,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMérieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.
In addition, bioMérieux offers a competitive Total Rewards package that may include:
A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].
BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
Show more Show less