Quality Control Operations Manager Jobs in Surrey, BC

Who we are:

Response Biomedical Corp. (Response) has been transforming acute care diagnostic testing with a focus on improving patient outcomes for over 30 years. We are a Canadian-owned company that develops, manufactures and distributes immunoassays around the world. We believe the people we work with, including our partners, healthcare teams, and employees are the cornerstone of our success.

What we do:

The RAMP platform is a global leader in cardiovascular and acute care testing for the triage and diagnosis of life-threatening diseases directly from whole blood samples.
We understand the stresses associated with rapid and accurate diagnosis when every minute counts and we are committed to providing lab-quality results within minutes while reducing the total cost of care.

Who we are looking for?

We are searching for an Quality Control Specialist to join our Quality Control team that is ready for a challenge and looking to make a difference. The successful candidate will be responsible for the testing of incoming raw materials, completing in process inspections for manufacturing, and the analytical testing of components and finished products to ensure that quality standards and procedures are met and aligned with legislation and required specifications. The Quality Control Specialist is also responsible for monitoring QC specifications and metrics to identify trends in established controlled processes and procedures, for the core purpose of improving patient outcomes and saving lives globally.

Key Responsibilities:

Quality Control

• Performs QC testing of incoming raw material, in-process components and finished products as part of routine QC and batch release activities for RAMP products including complex data analysis in accordance with approved procedures, specifications, and acceptance criteria.
• Performs OOS investigations and generates or supports investigation documentation to support manufacturing troubleshooting, complaint handling, and quality system activities.
• Performs monitoring stability study testing and supports completion of stability study documentation as required.
• Performs validation testing required for analytical method development, method verification, or QC process improvement activities.
• Supports analytical method development and testing activities required to maintain or improve QC methods.
• Reviews QC documents for all QC testing, including testing that requires complex data analysis, to ensure that results are accurate, complete, and meet specifications.
• Continuously reviews Q C data to identify trends, unusual results, or potential issues in established controlled processes and procedures.
• Collaborates with Product Development and Product Support on cross-functional projects related to QC testing, product performance, investigations, or process improvement.
• Edits DCOs and provides technical insights on improvement of QC testing procedures and acceptance criteria.
• Assists in organizing QC activities to meet operational targets, supports inventory counts and assists in resolving discrepancies as required.
• Performs laboratory housekeeping.

Manufacturing Support

• Provides QC testing support and technical input to Manufacturing as required while supporting manufacturing, QA, Product Development, and Product Support by performing testing or providing QC input related to troubleshooting, investigations, and product or process issues.
• Communicates testing status, technical observations, and quality concerns to support alignment between QC and Manufacturing activities.

Quality Systems

• Adheres to and enforces compliance with Quality Management System (QMS), GMP, GDP, ISO, and safety regulations, ensuring adherence to Standard Operating Procedures and Work Instructions.
• Ensures accurate and timely completion of regulatory and QC documentation, and reports quality and equipment issues to the QC Manager.
• Supports OOS, NC, CAPA, CCR, VR, and other quality system activities in accordance with QMS requirements including periodic review of QC documents and contributes to improvement of QC documentation quality.
• Supports continuous improvement of GMP, QMS, QC testing procedures, and acceptance criteria.
• Escalates quality concerns, documentation issues, testing risks, or abnormal results as appropriate.

Health and Safety

• Follows safety protocols and ensure proper handling of biohazardous materials, chemical reagents, QC samples, and laboratory equipment to maintain a compliant and safe work environment.
• Ensures that QC areas are kept clean and organized and reports safety concerns, equipment issues, and potential risks to the QC Manager or designate.

Education, Work Experience, Knowledge, and Skills:

Formal Education

• Post-secondary degree in Chemistry, Biology, Biochemistry, Medical Technology, or related fields.
• Occupational First Aid level 1 or higher is an asset.

Work Experience

• Minimum 2 years direct experience working in a regulated laboratory.
• Minimum 1 year experience in QC settings.
• Experience in analytical testing or medical device industry is preferred.
• Experience with OOS investigations, stability study testing, validation testing, QC document review, or DCO activities is preferred.
• Experience related to medical devices, protein biochemistry, and immunological methods is an asset.
  

Skills & Knowledge

• Proficient in Microsoft Office Suite, particularly Word and Excel.
• Experience in ERP systems for QC data input and management is preferred.
• Experience working with QMS, risk management, and NC/CAPA investigations.
• Strong understanding of QC testing processes, analytical methods, data analysis, and regulated laboratory practices.
• Ability to review QC documentation and testing data, including records requiring complex data analysis.
• Strong problem identification and problem resolution skills.
• Strong technical writing skills; excellent written and verbal communication.
• Demonstrated ability to work as part of an interdisciplinary team and independently in a professional environment.
• Excellent time management skills and ability to multi-task; able to complete tasks with flexibility in responding to changes in direction and priorities.
• Excellent organizational, interpersonal, and communication abilities, ensuring clear collaboration across teams.
• Knowledge of GMP, GDP, ISO 13485, GLP, MDSAP, Design Control, and worker safety requirements is an asset.
• Exhibits personal values that strongly align with the companys vision, values, and culture, contributing to a positive team environment.

The starting salary for this position ranges from $50,000 to $55,000 annually, depending on the candidate's experience and qualifications. Our salary structure is aligned with market standards and is finalized considering factors such as job-related expertise, skills, education, and experience.

Please note that this position is only available to candidates who are authorized to work in Canada.

*We regret that relocation will not be provided.

* While we appreciate the interest of all applicants, only those candidates selected for interview will be contacted.
We'recommitted to a diverse and inclusive workplace.We welcomeapplicants withoutregardto race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. All employment decisions are based on business needs, job requirements and individual qualifications.