Job Details

Quality Assurance Supervisor

📍 Bay Area, CA (On-site: Richmond, CA)

🕒 Full-Time

🏢 Confidential | Drug Testing Industry (Stealth Mode)

Peoplework LLC is looking for a highly motivated Quality Assurance Supervisor to join our client's team! The primary role will responsible for developing, establishing and maintaining quality systems programs, policies, processes, procedures, training materials, and controls enhancing the performance and quality of products todemonstrate conformance to established standards and regulations. This position reports to the SVP of Operations.

What You'll Be Responsible For

· Manage quality program for the company in support of new production line bring up, product related manufacturing activities and document control.

· Issuance of batch records and labels for commercial product manufacturing.

· Own production documentation review and product release, issuance of batch records and labels for commercial product manufacturing.

· Responsible for incoming receiving and QC activities.

· Lead complaint, CAPA, and training record initiation and completion.

· Assist troubleshooting activities, including root cause analysis, to achieve a timely resolution.

· Author and review relevant departmental documentation.

· Ensure compliance is adhered to for review requirement for all documents.

· Maintenance of controlled document program including upgrades to QMS when required.

· Provide support for document control function through routing, review, distribution, approval, and release of documents.

· Process Standard Operating Procedures, Batch Records, Validation Documents, Miscellaneous Reports, Forms, and Material Specifications through Greenlight Guru.

· Manage Training program, including initiation of training required as a result of new hire, document change, CAPA, etc.

· Management of the Document Control archive room including organization, filing and retrieval of documents as needed.

· Adherence to the Corporate and Company record retention policy for documents stored within the Document Control archive room.

· Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.

· Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.

· Establishes and maintains Quality milestones and timelines

· Represent Quality Systems as required in support of cross-functional team projects.

· Identify Quality Initiatives and lead cross-functional teams to complete them and provide guidance and direction of the Quality Systems Body-of-Knowledge

· Identify opportunities to apply, continuously improve, and redefine quality systems and controls for all divisional product-related processes in accordance with applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.

· Assist in hiring process and creation of relevant job descriptions.

· Manages staff; provides staff with coaching, training and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress toward goals and expectations.

Experience

· Bachelor's degree in science, engineering or related field.

· 5+ years professional experience in medical device or related fields.

· 1+ years of direct supervisory experience in an industrial setting.

· Experience working in a quality system environment, or related combination of education and work experience.

· Previous experience in medical device manufacturing environment.

· Effective planning and organizational skills, with the ability to prioritize, multitask and work with a high degree of accuracy and recall.

· Strong written, oral, interpersonal, group and telephone communication skills.

· Work with Subject Matter Experts to provide demonstrations as needed.

· Experience working with Electronic Document Management Systems preferred.

· Skilled in the use of Microsoft Office Products including Microsoft Word, Excel, PowerPoint, and Teams.

· Strong customer service skills.

Work Habits

· Ability to work independently and as part of an interdisciplinary team to achieve project goals and timelines is required.

· Strong verbal, written communication skills, including the ability to communicate efficiently with multiple people both internally and externally.

· Ability to prepare and present information to groups.

· Uses professional methods to contribute to the development of company concepts and principles and to achieve objectives in creative and effective ways.

· Ability to lead and motivate others in both matrixed and direct-line management environments.

Why This Role

• Join a confidential, early-stage drug testing company with meaningful impact on assay development and lab operations
• Opportunity to work closely with scientists, engineers, and quality teams
• Competitive compensation and benefits; salary range: $115,000-$120,000/year

🔒 Due to the stealth nature of the organization, additional details will be shared during the interview process.

Interested?

Apply directly or message me to learn more.