"Alerted.org

Title: Production Quality Engineering Manager

Schedule: M-F 9:00am- 5:00pm

Pay: $120-$150k, 10% bonus (bonus, excellent healthcare benefits, unlimited PTO

Type: Direct/Permanent

Start date: Immediate

Overview:

Our client a global medical device company, is currently seeking qualified candidates for the position a global leader to be the Production Quality Engineering Manager oversee and provide leadership for the Production Quality Engineering, Validation, and In-process testing teams. This role is integral in driving quality improvements in manufacturing, maintaining compliance to standards and regulations, and ensuring product testing is completed in timely and consistent manner.

Responsibilities:

+ Provides leadership and direction to the quality team, ensuring alignment with business and corporate objectives

+ Identifies and implements initiatives to reduce defects, enhance product quality, and improve quality system efficiency

+ Manages the Nonconformance process, ensuring timely investigations, thorough root cause analysis, and reduction of recurring issues

+ Collaborates with Production, Engineering, R&D, and external partners to ensure proper handling of changes and quality events

+ Participates in annual budget planning and ensures operations remain within financial targets

+ Develops, tracks, and reports key performance indicators (KPIs) for quality metrics

+ Analyzes quality data to identify trends and provides actionable insights to the management team

Requirements:

+ Bachelor’s degree required; B.S. in Engineering strongly preferred

+ Equivalent combination of education and experience may be considered

+ Strong leadership skills with experience guiding, coaching, and developing teams

+ Proven project management and problem-solving abilities

+ Skilled in mentoring and training staff in an organizational setting

+ Experienced in cross-functional collaboration with engineering, production, and quality teams

+ Effective communicator with strong verbal and written skills

+ Demonstrated ability to lead technical teams and influence decision-making across departments

+ Serves as primary technical contact on complex projects involving multiple stakeholders

+ Ability to build consensus and promote open, constructive communication

+ Deep knowledge of ISO 13485 and 21 CFR Part 820 quality system requirements

+ Experience working with regulatory agencies and supporting audits

+ Familiarity with cleanroom environments, sterilization processes, and product testing protocols

+ Able to clearly present complex technical data and respond to technical inquiries

+ Proficient in PC software applications and tools relevant to quality and engineering work

#M3

#LI-GS1

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.