Quality Engineer

Bio-Techne • San Marcos, CA

1d

About The Position

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 - $120,200.00 Responsible for supporting Quality Engineering requirements for change control, continuous improvement, and customer complaints handling and satisfaction. Will serve as a subject matter expert and liaison between company and customers with the goal of resolving quality and manufacturing issues and ensuring positive channels of communication to ensure customer satisfaction.

Requirements

• Bachelor of Science degree in Quality, Biology, Chemistry or similar.
• Minimum 2 years’ experience as a Quality professional in a manufacturing environment.
• Proficient in understanding and application of ISO13485.
• 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.

Nice To Haves

• Diagnostics, pharmaceutical or Biological products manufacturing environment is preferred.
• Auditing, Six Sigma and Lean Manufacturing experience a plus.

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.
• Responsible for change control process, perform risk assessment and facilitate the change control plan writing and execution.
• Monitor change implementation process and close change plan in a timely manner.
• Responsible for implementation and validation of a new electronic Quality Management System.
• Prepare quality information and trending data to be shared in the management review meeting.
• Enable positive communication channels internally and externally to ensure the highest level of customer satisfaction.
• Actively participate in internal, customer, and third-party audits.
• Other duties as assigned.

Benefits

• competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
• an accrued leave policy with paid holidays, paid time off, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level