Quality Systems Specialist - Risk Management (Hybrid)
Full-time 11 hours ago Full Job Description Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics.
Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.
That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization.
External applicants must be eligible to work in the US.
Your Role:
MilliporeSigma in Rocklin, CA is hiring a Quality Systems Specialist.
The Quality Systems Specialist will be part of the Quality team and responsible for providing quality support for the site quality management system.
This position ensures compliance of the quality system with regulations relevant to the business, including but not limited to, ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, and the quality manual.
This position is multi-disciplinary with opportunities to work on future and current product and process improvements.
The position will represent Quality on cross-functional teams to support business needs and may lead quality initiatives driving a positive site quality culture.
The position prepares Quality System documents and reports as needed for Rocklin site metrics and management review.
Responsibilities:
Manage and lead Risk Management process per ISO 14971 standard requirements.
Coordinate and apply as needed to site processes, product design and usability.
Lead and direct investigations, RCA, and CAPA while providing guidance and support for risk management activities Write, revise and/or review Standard Operating Procedures while understanding and following the requirements of the quality system Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and policies Supports internal and external audits as required Understand, support, and communicate Company mission, vision, and values Maintain current training requirements and train other staff members as requested Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies Recommend, provide, or initiate solutions by actively providing suggestions for improvement Follow regulatory and standard requirements as applicable to the site, i.
e.
MDSAP, ISO 13485, IVDR, and compliance to the site Quality Manual Review and approve quality documentation and records Collaborate and coordinate with external stakeholders to identify, escalate, and resolve quality issues Identify and rectify process gaps, implementing robust solutions This position may include work on weekends or extended hours as needed Who You Are:
Minimum
Qualifications:
Bachelor's degree in Chemistry, Biotechnology, or other Science field with 3
years of Quality experience working in a drug manufacturing, medical device, or biologic industry in Quality Assurance position managing a risk management process OR Associate degree in Chemistry, Biotechnology, or other Science field with 5
years of Quality experience working in a drug manufacturing, medical device, or biologic industry in Quality Assurance position managing a risk management process OR High School diploma or GED with 8
years of Quality experience working in a drug manufacturing, medical device, or biologic industry in Quality Assurance position managing a risk management process Preferred
Qualifications:
General understanding of the principles and practices of managing a product line from research and development phase all the way to distribution Excellent understanding of QSR's, cGMP, ISO 9001, ISO 13485 and other standards and regulations applicable to QMS In depth understanding of ISO 14971:
2019 and other standards and regulations applicable to risk management related to medical devices Statistical knowledge and/or project planning skills.
Ability to solve complex problems related to quality system issues, production, customer and/or supplier related concerns.
Excellent analytical skills Excellent oral and written communication skills Self-directed and self-motivated with excellent organizational skills with ability to prioritize and work effectively on multiple tasks Ability to apply knowledge of regulations and standards to Quality processes Able to work well in a team environment and work and communicate effectively with all areas and levels of the organization Experience with calendaring, word processing, and spreadsheet software.
Highly proficient with Microsoft Office Suite (Word, Excel, PowerPoint) Pay Range for this position - $49,500 - $148,900 Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data.
Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors.
This role may offer the following
Benefits:
medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits.
This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.
What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology.
We are committed to creating access and opportunities for all to develop and grow at your own pace.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team! If you would like to know more about what diversity, equity, and inclusion means to us, please visit https:
//www.
emdgroup.
com/en/company/press-positions.
html.
Estimated Salary: $20 to $28 per hour based on qualifications.
Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.
That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization.
External applicants must be eligible to work in the US.
Your Role:
MilliporeSigma in Rocklin, CA is hiring a Quality Systems Specialist.
The Quality Systems Specialist will be part of the Quality team and responsible for providing quality support for the site quality management system.
This position ensures compliance of the quality system with regulations relevant to the business, including but not limited to, ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, and the quality manual.
This position is multi-disciplinary with opportunities to work on future and current product and process improvements.
The position will represent Quality on cross-functional teams to support business needs and may lead quality initiatives driving a positive site quality culture.
The position prepares Quality System documents and reports as needed for Rocklin site metrics and management review.
Responsibilities:
Manage and lead Risk Management process per ISO 14971 standard requirements.
Coordinate and apply as needed to site processes, product design and usability.
Lead and direct investigations, RCA, and CAPA while providing guidance and support for risk management activities Write, revise and/or review Standard Operating Procedures while understanding and following the requirements of the quality system Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and policies Supports internal and external audits as required Understand, support, and communicate Company mission, vision, and values Maintain current training requirements and train other staff members as requested Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies Recommend, provide, or initiate solutions by actively providing suggestions for improvement Follow regulatory and standard requirements as applicable to the site, i.
e.
MDSAP, ISO 13485, IVDR, and compliance to the site Quality Manual Review and approve quality documentation and records Collaborate and coordinate with external stakeholders to identify, escalate, and resolve quality issues Identify and rectify process gaps, implementing robust solutions This position may include work on weekends or extended hours as needed Who You Are:
Minimum
Qualifications:
Bachelor's degree in Chemistry, Biotechnology, or other Science field with 3
years of Quality experience working in a drug manufacturing, medical device, or biologic industry in Quality Assurance position managing a risk management process OR Associate degree in Chemistry, Biotechnology, or other Science field with 5
years of Quality experience working in a drug manufacturing, medical device, or biologic industry in Quality Assurance position managing a risk management process OR High School diploma or GED with 8
years of Quality experience working in a drug manufacturing, medical device, or biologic industry in Quality Assurance position managing a risk management process Preferred
Qualifications:
General understanding of the principles and practices of managing a product line from research and development phase all the way to distribution Excellent understanding of QSR's, cGMP, ISO 9001, ISO 13485 and other standards and regulations applicable to QMS In depth understanding of ISO 14971:
2019 and other standards and regulations applicable to risk management related to medical devices Statistical knowledge and/or project planning skills.
Ability to solve complex problems related to quality system issues, production, customer and/or supplier related concerns.
Excellent analytical skills Excellent oral and written communication skills Self-directed and self-motivated with excellent organizational skills with ability to prioritize and work effectively on multiple tasks Ability to apply knowledge of regulations and standards to Quality processes Able to work well in a team environment and work and communicate effectively with all areas and levels of the organization Experience with calendaring, word processing, and spreadsheet software.
Highly proficient with Microsoft Office Suite (Word, Excel, PowerPoint) Pay Range for this position - $49,500 - $148,900 Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data.
Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors.
This role may offer the following
Benefits:
medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits.
This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.
What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology.
We are committed to creating access and opportunities for all to develop and grow at your own pace.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team! If you would like to know more about what diversity, equity, and inclusion means to us, please visit https:
//www.
emdgroup.
com/en/company/press-positions.
html.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
