Director of Corporate Quality

New Team LLC•Forest Lake, MN

1d•$160,000 - $220,000•Onsite

About The Position

Velosity is searching for a Director of Corporate Quality to support our multi-site contract manufacturing business serving the Medical and Defense sectors. This role designs and executes Velosity’s total quality management strategy. Directs and leads the team responsible for the implementation, administration, and measurement of total quality management programs. Directs all aspects of the Quality Management System (QMS) to ensure compliance with applicable regulatory and customer requirements in a contract manufacturing environment serving the medical device and defense industry. This role provides strategic and operational leadership in quality assurance, quality control, and regulatory compliance, fostering a culture of continuous improvement, risk management, and customer satisfaction.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related field; Master’s degree a plus.
Minimum of 15 years of experience in Quality Assurance including at least 10 years in the contract manufacturing industry, ideally including the medical device segment; solid knowledge of plastics and metals processing is required.
Minimum 8 years in a leadership role.
Experience in contract manufacturing or OEM environments is required.
Deep understanding of ISO 13485, AS9100D.
Experience with risk management (ISO 14971), and design and process controls, and validation (IQ/OQ/PQ).
Strong knowledge of CAPA, root cause analysis (RCA), and statistical quality tools and the scientific molding approach (e.g., SPC, statistics software).
Proficient in QMS software and document control systems.
Strategic thinker with the ability to execute operationally.
Excellent communication, negotiation, and interpersonal skills.
Strong leadership and team management skills, with a demonstrated ability to motivate, mentor and guide a diverse team of Quality professionals.
Proven ability to lead teams through change and growth.
Financial understanding including budget development and cost analysis.
Ability to work independently with limited supervision; to solve practical problems; to work effectively with other departments and to manage multiple priorities.
Local travel will be required between Velosity sites; Approximately 10% domestic or international travel may be required for customer visits, supplier audits, trade shows, or industry events.
Due to ITAR regulations, this role is only open to U.S. Citizens, lawful permanent residents (green card holders) or foreign nationals granted refugee or asylee status. Individuals with temporary visas (e.g. E, F-1, H-1, H-2, L, B, J, TN or OPT) are not eligible for hire in this role.

Nice To Haves

Master’s degree a plus.

Responsibilities

Establish the Quality department’s strategic vision, goals, and objectives in alignment with Velosity’s business plans.
Develop, implement, and maintain a robust Quality Management System in accordance with ISO 13485, FDA 21 CFR Part 820, MDSAP, AS9100D, and other global regulatory standards, moving to standardize the system across all locations.
Serve as the Management Representative for the QMS, ensuring compliance and readiness for audits and inspections.
Drive a culture of quality excellence by integrating best practices into daily operations in partnership with the manufacturing organization.
Oversee internal and external audits including FDA inspections, ISO certifications, and customer audits.
Oversee CAPA (Corrective and Preventive Action), non-conformance investigations, and risk management activities.
Ensure timely reporting and resolution of quality issues, including customer complaints and field actions.
Utilize risk management frameworks to proactively identify and mitigate quality related risks.
Develop and implement total quality processes and procedures.
Oversee incoming, in-process, and final product quality inspections and related activities to ensure consistent product quality and conformance to specifications.
Implement and monitor in partnership with manufacturing key quality performance indicators (KPIs), including scrap, rework, yield, and customer returns.
Manage validation and qualification activities (equipment, process, software, cleaning, etc.).
Collaborate with Engineering, Operations, and Supply Chain functions to ensure quality is embedded in all elements of manufacturing.
Execute supplier quality initiatives, including supplier audits, performance monitoring, and supplier corrective actions (SCAR’s).
Act as the primary quality interface with customers, providing quality data, addressing quality concerns, and working with supplier engineering to facilitate continuous improvement initiatives.
Utilize Lean, Six Sigma and other methodologies to enhance efficiency and reduce defects.
Develop and monitor key performance indicators (KPIs) to identify areas for component and process quality improvement.
Foster a culture of operational excellence by promoting innovation in quality processes.
Build, lead, and mentor a high-performing quality team, including QA, QC, document control, metrology, internal audit and validation personnel across all sites of Velosity.
Foster a culture of accountability, quality ownership, and continuous improvement throughout the organization.