The Quality Engineer will play a key role in supporting Bio-Rad's design control process including risk management, design history file, verification and validation support throughout the new product development process for numerous Life Science (LSG) and Clinical Diagnostics (CDG) products.How You'll Make An Impact:
How You'll Make An Impact:
- Support the New Product Development process, work with the Design History File (DHF) and Device Master
- Record (DMR) and ensure that design projects comply with internal design control procedures in accordance with FDA and ISO requirements.
- Provide guidance functional teams to ensure that applicable design control requirements are being achieved including those related to design inputs, outputs, verification, validation, risk management and design history files.
- Establishing a strategy and step by step approach for Risk Management and related Technical File documentation to ensure compliance with FDA QSR, MDSAP, EU IVDR, ISO 14971:2019 and IEC 62366-1:2015 requirements. Also leading and overseeing a risk-based work plan to accomplish the strategy within fixed project schedules.
- Compiling and analyzing information to identify unacceptable trends and benefit-risk conclusions with the goal of driving suitable corrective actions needed to maintain safe and effective products.
- Contributing to and/or reviewing health hazard analyses and product risk assessments for issues potentially impacting patient outcomes or product performance.
- Assessing technical product and QMS documentation such as test protocols, reports, manufacturing procedures, supplier files, process flow diagrams and drawings in support of the design control process.
- Assess and update, as required, product risk management files related to design updates, use risks, risk controls and mitigation throughout the design control process.
- Provide guidance in external compliance requirements such as safety, EMC, RoHS, China RoHS, WEEE, Cybersecurity.
- Represent the QA function at Design Reviews.
- Mentoring peers, project team members and lower level Quality Engineers in the application of risk management and design control requirements and industry best practices.
- Supporting a wide range of continuous and process improvement initiatives, including creating process flow maps, procedures and training materials.
- Support other quality and compliance activities as required including supporting regulatory submissions, manufacturing activities, audits and inspections.
- Help to drive and foster a quality environment and mindset throughout the business.
This position is eligible for a $10,000 HIRING BONUS:
- Bachelors degree or equivalent in Engineering, Biology, Chemistry, or related field.
- 5+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.
- Full knowledge of and application of Design Control, Quality Engineering and Risk Management required.
- Thorough understanding of GMP/ISO regulations (ISO 14971, ISO 13485, IEC 62366, MDSAP, IVDR and FDA 820/210/211)
- Detail-oriented, excellent organization and project management skills are needed to meet expectations.
- Decision making, time management, communication, leadership, and computer skills.
- SalesForce, SAP and Power BI experiences, Six Sigma Green or Black Belt certification is a plus
Offered for a limited time only. Applicable to specific positions as labeled. Recipients must be employed at the time of payout. Payout after 30 days of employment with Bio-Rad. Offered to direct hires only. Agency hires and internal transfers are not eligible. 12 months repayment clause.Vaccination Requirement:
Ability and consent to upload proof of completed Covid-19 vaccination into our secure database within 3 days of start date.Total Rewards Package:
At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle.Who We Are:
For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.Benefits:
Bio-Rad's biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, affordability, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle. We're proud to offer rich options, including no-cost medical plans, free HSA money, a new fertility offering with stipend, life and disability, paid parental leave, 401k plus profit sharing, employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges, time off, ERG's, and more!Compensation:
The estimated base salary range for this position is $127,000 to $174,700 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.EEO Statement:
Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.Agency Non-Solicitation:
Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.