What are the responsibilities and job description for the Quality Engineer position at Research & Diagnostic Systems, Inc.?
By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
Pay Range:
$73,100.00 - $120,200.00Responsible for supporting Quality Engineering requirements for new product development, legacy
product maintenance activities, continuous improvement, risk management and customer
satisfaction. Will serve as a subject matter expert and liaison between company and
customers/vendors with the goal of resolving quality and manufacturing issues and ensuring
positive channels of communication to ensure customer satisfaction.
Duties and Responsibilities:
· Key member of complaint and MRB investigation teams. Analyze, identify, develop and
implement manufacturing, production, and other process improvements which will improve
capability, and/or performance. Meet with appropriate teams and/or individuals to offer
recommendations and share results.
· Create Failure Mode and Effects Analysis (FMEA) for new and existing products based on
risk assessment and in alignment with ISO 14971:2019. Collaborate with R&D and
Regulatory department personnel to align risks identified and mitigations to reduce and
control risk.
· Quality representative for new equipment program. Evaluate new equipment for validation
requirements. Act as a reviewer/approver on equipment validations performed by other
departments.
· Represent the company via interactions with Suppliers including new products, Supplier
Corrective Action Reports, change notifications, etc. Review SCARs sent back from
suppliers to assess corrective actions. Conduct and/or participate in supplier audits.
· Represent Quality on new product development teams and transition new designs into
production. Work closely with Operations personnel to develop strategy and plans for
implementation.
· Schedule and lead periodic cross-functional meetings to review the Validation Program.
Recommend process/equipment candidates for re-validation based on changes to
operations, processes and practices. Write, review, and approve validations, when
necessary, (installation qualification IQ/operational qualification, OQ/performance
qualification PQ protocols, Standard Operating Procedures (SOP), technical reports, and
final reports) for new products, processes, and equipment; ensure systems, utilities, and
processes comply with the Food and Drug Administration (FDA) and industry standards.
· Participate in management review meetings and/or prepare information and trending data to
be shared in the meeting.
· Enable positive communication channels internally and externally to ensure the highest level
of customer satisfaction.
· Develop, prepare, and implement Quality Program plans for new and existing customers
specific to validation and qualification activities.
· Author new or revised SOPs per the QMS while ensuring consistency of processes, verbiage and taking into consideration personnel in each functional area. Act as a signatory in Change Control when necessary. · Actively participate in internal, customer, and third-party audits. · Other duties as assigned.
Knowledge, Skills and Abilities Required:
· Manage time wisely and effectively prioritize multiple competing tasks.
· Ability to identify and solve problems, develop innovate solutions, act decisively and apply
good judgement.
· Readily able to offer opinions and take action when the position may be unpopular.
· Skilled at handling situations diplomatically.
· Proven team player who has demonstrated capabilities in the following areas: excellent
communication, interpersonal skills, well developed problem-solving skills; solid
organizational skills and the demonstrated ability to be self-directed and effectively relate to
all levels of the organization.
· Strong computer skills a must, to include Word, Excel, PowerPoint; experience with Access
Database is a plus.
Minimum Job Requirements: Bachelor of Science degree in Quality or Mechanical Engineering or
similar. Minimum 5 years’ experience as a Quality Engineer in a manufacturing environment.
Diagnostics, pharmaceutical or Biological products manufacturing environment is preferred.
Proficient in understanding and application of ISO13485. Auditing, Six Sigma and Lean
Manufacturing experience a plus.
Why Join Bio-Techne:
We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Bio-Techne is an E-Verify Employer in the United States.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.
Salary : $73,100 - $120,200
