Manager, QA

Description

You will lead the Quality Engineering team and give it technical direction across the full product and process lifecycle.

Your scope covers design and new product introduction, risk management, nonconformances, deviations, CAPAs, complaints and continuous improvement.

You will work with Engineering, Operations, R&D and Supply Chain so that quality and compliance needs shape product and process decisions, and so that risks are found, controlled and fixed for good.

You report to the Senior Manager, Quality and are accountable for the team's performance, capability and growth, and for building a proactive, risk-based quality culture.

You own the technical quality of investigations and risk decisions, not just the completion of workflow steps, so you help prevent recurrence and improve product and process performance.

Success is measured by right-first-time performance, fewer repeat nonconformances and deviations, CAPA quality and timeliness, on-time NPI delivery, lower product and process risk, complaint and defect trends, audit readiness, finished improvement projects, and the team's development.

Responsibilities

• Set clear responsibilities, priorities and performance expectations for the Quality Engineering team, and coach and develop its members.
• Assign QE resources day to day based on product, project, compliance and business risk.
• Grow the team's technical skills through coaching, development plans, cross-training and standard QE practices.
• Set QE performance metrics, track them, and use the data to spot risks, trends and improvement opportunities.
• Give technical guidance and escalation support on complex or high-risk quality issues.
• Foster accountability, collaboration, continuous improvement and ownership of quality.
• Create simpler procedures and workflows that keep compliance high and meet documentation requirements under 21 CFR Part 820, ISO 13485, ISO 14971, IVDD, IVDR and/or MDSAP.
• Make sure CAPAs, nonconformances, deviations and complaints follow company procedure, and coach teams through each step.
• Run regular inter-department and cross-functional review boards so identified issues are reviewed and resolved on time, in line with company goals and regulatory requirements.
• Lead Quality Engineering input to product and process design, development and transfer, including design controls and NPI.
• Work with Engineering and other functions to build quality requirements and risk controls into development early.
• Support design reviews, process reviews, qualification and validation, change implementation and manufacturing readiness.
• Make sure QE deliverables for NPI projects are defined, resourced and completed to project requirements.
• Find potential product and process risks before they are implemented, and drive mitigation.
• Lead and facilitate risk management for products, processes and changes.
• Make sure risk assessments are technically sound, well documented and turned into working controls.
• Encourage consistent risk-based decision making across functions.
• Make sure emerging risks from complaints, deviations, nonconformances, CAPAs and operational data are evaluated and built into ongoing risk management.
• Oversee post-market surveillance and vigilance activities.
• Oversee QE work on nonconformances and deviations, ensuring investigations are timely and technically sound.
• Ensure containment, product-impact assessment, root-cause analysis and disposition of affected material and product are done properly.
• Work with other functions to cut repeat events and improve right-first-time results.
• Track nonconformance and deviation trends and start systemic improvements early.
• Provide leadership and technical oversight for corrective and preventive actions.
• Make sure investigations find true root causes where possible, and that CAPA plans address systemic issues.
• Ensure CAPA actions are risk based, finished on time, and verified for effectiveness.
• Analyse CAPA trends and find ways to prevent recurrence across products, processes and operations.
• Support complaint investigations where manufacturing, product or process expertise is needed.
• Link complaint findings to risk management, CAPA, nonconformance and continuous-improvement processes.
• Identify and escalate significant or recurring product quality trends.
• Lead or support QE initiatives that improve product quality, process capability, reliability and operational performance.
• Use quality data, statistical methods and trend analysis to find proactive improvement opportunities.
• Work with Operations and Engineering to reduce defects, deviations, scrap and rework.
• Standardise and simplify QE processes and tools.
• Champion Lean, problem solving and continuous-improvement methods within the QE group.
• Make sure QE activities meet applicable regulations, standards, procedures and the company Quality System.
• Act as the QE subject-matter lead for internal, customer and regulatory audits and inspections.
• Make sure audit findings tied to QE are investigated and closed out effectively.
• Keep the function ready for inspection.
• Escalate significant product quality, compliance or business risks to the Senior Manager, Quality without delay.
• Provide QE metrics, trends, risks and improvement plans for management review and other quality governance.
• Be the main QE partner to Operations, Engineering and product development functions.
• Shape cross-functional decisions so that product quality, customer impact, compliance and business risk are weighed properly.
• Build working relationships across functions and settle competing priorities using risk-based decisions.
• Represent QE on project teams, operational reviews and other cross-functional forums.
• Turn quality requirements into practical solutions that support the business while keeping compliance and product quality controls in place.
• Recruit, onboard, coach and retain a capable QE team.
• Set individual objectives aligned with quality and business priorities.
• Hold performance and development discussions and give timely feedback.
• Build technical depth and succession cover within the QE team.
• Build a team that acts as proactive business partners and technical problem solvers, not mainly as reviewers or approvers.

Requirements

• Required: a bachelor's degree in engineering, science, quality or a related technical field, or comparable experience in its place.
• Required: typically 7+ years of progressive experience in quality engineering, manufacturing engineering, product engineering or a related technical role in a regulated environment.
• Required: knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, IVDD, IVDR and/or MDSAP, and the ability to apply them.
• Required: previous people leadership, supervision and/or proven technical leadership.
• Required: proven experience with nonconformance and deviation investigations, CAPA, root-cause analysis and risk management.
• Required: experience with product or process changes, design activities, manufacturing operations and/or new product introduction.
• Required: strong analytical skills and structured problem solving, including troubleshooting.
• Required: proven ability to influence and collaborate across Engineering, Operations and other functions.
• Required: strong written and verbal communication, with the skill to handle difficult situations thoughtfully and work with people at every level.
• Required: self-directed, able to work without close supervision and still produce quality work.
• Required: sound decision making and a clear sense of when to escalate.
• Required: proficiency in MS Office (Outlook, PowerPoint, Word, Excel and Visio), Microsoft Teams, Smartsheet and Adobe Acrobat.
• Required: experience managing people and developing talent.
• Preferred: working knowledge of statistical quality engineering techniques and process capability, and Power BI.
• Preferred: Lean or Six Sigma experience or certification.
• Preferred: ASQ CQE, CMQ/OE or a related certification.
• Preferred: experience leading quality engineers in a complex manufacturing environment.

Conditions

The company is hiring a Manager, Quality for its Quality Assurance leadership team in Fremont, CA.

The estimated salary range for this California role is $112,500.00 to $150,000.00.

Standard schedule, Monday to Friday.

Work is based in the office.

Benefits

• Eligible for a variable annual bonus based on company, team and/or individual results, per company policy.
• A choice of national medical and dental plans, a national vision plan, and health incentive programs.
• Employee assistance and family support programs, commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off, 10 paid holidays a year, and paid parental leave of 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance, plus short- and long-term disability, per company policy.
• 401(k) U.S. retirement savings plan.
• Employee Stock Purchase Plan, letting eligible staff buy company stock at a discount.
• Full benefit details are published on the company's total rewards page.