Director Quality Operations Jobs

­Are you ready to work for a more active world?

At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

Who is Bioventus?

We are the market leader in developing clinically proven and cost-effective solutions for pain treatment & joint preservation, restorative therapies and surgical solutions. Our products are recognized for their safety, innovation and effectiveness.

$500+ million in annual revenue

1100+ employees worldwide

Helping 700,000+ people every year

The Bioventus team always puts patients at the forefront, and their needs are the priority in the choices we make and actions we take.

Director Quality Assurance Operations

Full time – Onsite – Memphis, TN

Reporting directly to the Executive Leadership Team.

The Director of Quality Assurance Operations supports the Bioventus business and quality functions by ensuring that the core Quality Assurance, Sustaining Engineering and Quality Control of the Quality Management System functions are functioning in a compliant manner and with a high level of operational performance. Key functions include Supplier Quality Management and Controls, Quality Sustaining engineering and Process controls, Quality Control activities, including inspections, manufacturing process controls, and calibration, and validation services (IT, internal and external processes).

What you'll be doing

• Manages review of engineering and/or regulatory changes to assess their impact on quality systems and address deficiencies.
• Manages supplier management process. (risk assessments, audits, SCAPAs,) and ensures SME and process owners for QMS systems (including databases) to collect, monitor and trend data within areas of responsibility.
• Participates in continuous improvement programs; Works with cross functional teams such as manufacturing, IT, suppliers and R&D to improve the current processes where needed.
• Proficient with SAP applications that track data on product conformity, process performance (inspection, rejects, release metrics, etc.)
• Works with multiple project schedules and manages competing priorities
• Ensures Company’s processes, procedures, specifications, policies and records continuously comply with Federal, international and other external regulations and requirements.
• Prepares and supports the organization for audits and ensures successful completion, including follow-up activities.
• Creates Bioventus organizational processes and systems to support the QA, quality engineering and associated functions.
• Manages internal and external audits and Inspections as needed.
• Performs other related duties as assigned
• Supports QA and QC improvement efforts including Corrective and Preventive Action, Lean/Six Sigma
• Establishes a team that can support and maintain the systems and processes on an ongoing basis. Coaches and manages performance of direct reports, ensures focus on functional and company objectives. Conducts full performance management cycle. Manages Quality Engineering team to ensure availability and capability of staff supporting operational needs, including outsourced operations. Ensures staff capability to generate, analyze, and present reports on quality related Key Performance Indicators (KPI) such as supplier performance, scorecards, project completion, etc.
• Manages development/implementation of quality control training programs for quality function.
• Leads the Sustaining Quality Engineering, Quality Control and Supplier Quality functions and manages the applicable Quality Management System policies, procedures and compliance to Medical Device Directive and global Quality System Regulations

What you'll bring to the table:

• Working knowledge of Microsoft Office software (Word, Excel, PowerPoint, and Outlook) and fundamental quality tools.
• Broad understanding of regulatory and compliance issues that drive the medical device industry, including those outside of the area of his/her expertise.
• Extensive knowledge of global quality system regulations, MDR reporting system and adverse event processes (US, CAN, EU, AUS, etc.).
• Work well within a team and relate to all levels within the company
• Strong computer skills including database or IT validation experience.
• Good verbal/written communication skills with an investigative mindset and critical analysis skills.
• Bachelor degree in biology, health sciences, engineering, nursing or other related discipline.
• Minimum 10 years’ experience within a Quality Assurance, Quality Control, or Manufacturing Engineering department in the medical device industry.

What you’ll receive

• We value others and build success by appreciating differences in thought, opinion, background, skills and perspectives
• Exciting benefits package, including vacation; medical, dental and vision benefits; Student Debt Program; life insurance; and a 401(k) plan
• Flat organizational structures which elevate employees’ level of responsibility
• An environment of continuous learning and development
• Meaningful opportunities for professional development and mentoring
• The satisfaction of driving real change in the industry and people’s lives
• Competitive compensation package, including salary and bonus.
• A business that acts with integrity in all interactions with co-workers, leaders and customers
• A diverse global community of people who are driven by a shared purpose to help patients

Are you the top talent we are looking for?

Apply now! Hit the “Apply” button to send us your resume and cover letter.

Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity, and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, ability, gender, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.

Bioventus requires proof that new hires be fully vaccinated against COVID-19, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents you from being vaccinated where allowable under the law. Documentation is required to be uploaded within the first week of employment.